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Amputations are relevant problems not only for the surgeon. Physicians and dialectologists are also involved into the wound treatment, the coordination of the attending problems which leads to impaired wound healing (e.g. hyperglycaemia, infection, arterial occlusive disease). Internists should be part of the interdisciplinary setting and also of the decision for the necessary amputation. A well coordinated and interdisciplinary procedure allows to control appearing wound healing disturbances and to receive a functionally optimal result by employing minimal surgical interventions.

The main causes for amputations on the lower extremities are dysvascular disease and/or diabetes mellitus. Especially in diabetics tissue preserving surgical techniques should be performed. Due to multimorbidity and high risk of an amputation on the other extremity, the so called "major amputations" ("transtibial" or "transfemoral") should be reduced. Especially in diabetics tissue preserving amputations on the foot or resection techniques on the foot are of importance to prevent major disabilities or handicaps on the patients. For this the surgeon has to have knowledge on all amputation levels on the foot as well as knowledge about prosthetic fitting or shoe techniques. With this a high percentage of good results will prevent the patient from major amputations.

Background: The efficacy of custom-made shoes to prevent diabetic foot ulcerations is still unsatisfactory and specific conception is lacking., Method and Patients: We conducted a prospective study on 32 consecutive patients with diabetic mellitus, sensitive neuropathy and healed minor amputation of the foot. They were following a prevention program (education, medical consultation every month). They were treated by custom-made shoes in order to obtain a tested and effective load-off area (after trying and modifying a temporary footwear according to a simple qualitative test of the plantar pressure)., Results: At 1 year, 9% of patients presented a new foot ulceration and 3% new minor amputations of the foot. The custom-made shoes had very thick multiple layer total-contact soles (mean thickness 25 mm for a forefoot deformity and 40 mm for a mid-foot deformity)., Conclusion: This new concept of custom-made shoes might be effective in enhancing the prevention of neuropathic ulcerations for high-risk patients. A randomized controlled trial would be needed to establish sound evidence supporting this new approach for therapeutic footwear.

Background: Exercise has not been studied extensively in persons with active neuropathic diabetic foot wounds, primarily because a device does not exist that allows patients to exercise while sufficiently off-loading pressure at the ulcer site. The purpose of this project was to demonstrate a device that reduces cycling plantar forefoot pressure., Methods: Ten healthy participants rode a recumbent bicycle under three cycling conditions. While the left foot interaction remained constant with a standard gym shoe and pedal, the right foot was exposed to a control condition with standard gym shoe and pedal, gym shoe and specialized cleat, and gym shoe with an off-loading insole and specialized cleat. Pressure and contact area of the plantar aspect of the feet were recorded for a 10-sec interval once during each minute of each condition's 7-min trial., Results: The off-loading insole and specialized cleat condition yielded significantly lower (P < .01) peak pressure, contact area, and pressure-time integral values in the forefoot than the specialized cleat condition with gym shoe, which yielded significantly lower values (P < .01) than the standard gym shoe and pedal., Conclusion: Modifications to footwear may alter plantar forefoot pressures, contact area, and pressure-time integrals while cycling. The CLEAR Cleat could play a significant role in the facilitation of fitness in patients with (or at high risk for) neuropathic wounds.

Although total contact casting provides pressure relief and a moist wound-healing modality that allows patients to resume mobility while the wound is healing, it is not as widely used as it should be, in part because Board-certified pedorthists with relevant skills are scarce. As a result, clinicians may not appreciate the positive impact total contact casting has on the patient's overall condition. This case study of a 75-year-old woman with a potentially life-threatening diabetic foot ulcer offers a comprehensive picture of pervasive physiological changes in a context of challenging comorbidities. This multifaceted case is presented against a backdrop of Sister Callista Roy's nursing theory of adaptation and a total patient care approach to illustrate the cascading effects of diabetes on the patient's well-being, as well as to show that total contact casting is not only an effective intervention in the management of the patient's diabetic foot ulcer, but also a way to improve the patient's overall condition by maximizing the benefits of mobility.

Those working with patients with diabetic foot wounds are well aware that individuals who take a considerable time to heal pose ongoing challenges for health care professionals and informal carers; cycles of breakdown, recurrent infections, pain management, and adherence to treatment all require regular reassessment, renegotiation of care goals, and review of care plans. Those patients with ulcers for many years are clearly hard-to-heal and often reach a state where the wound is 'static'-not always with any apparent reason. Whilst such scenarios lead professionals to feel exasperated by the lack of progress-how often do we fully consider what this must be like from the patient's point of view? This article will focus on aspects of educational research and health psychology that can lead to a clearer understanding of ways in which professionals can negotiate with patients and empower them to take more responsibility for their own health, within a framework that clearly distinguishes between 'compliance', 'adherence', and 'concordance'. Motivation is fundamental to adherence; the key to developing individual motivation is personal self-awareness and knowledge. However, education on its own will not lead to behaviour change. Readiness to change, confidence in having the necessary skills and family support are key factors when structuring behavioural change programmes.

Diabetic foot ulcers (DFU) are a common co-morbidity affecting patients with diabetes. A variety of factors, including diabetic peripheral neuropathy, altered gait, and increased pressure on certain regions of the foot, can over time result in a diabetic foot wound. Reducing pressure at the site of the ulcer can promote healing and prevent further ulceration. Offloading is an evidence-based treatment modality for patients with DFUs and is part of the standard protocol for treatment. We discuss here the most common offloading modalities, placing them in the context of relevant medical and compliance issues that affect their use and success.

Unlabelled: The Internet has become a major source of health information for consumers. Nevertheless the quality of medical information varies widely and is generally poor., Aim: This study aimed to evaluate the quality of information delivered on French-speaking Internet about the diabetic foot., Methods: Websites were selected using three popular search engines and introducing "foot+diabetes" and "foot+diabetic" as keywords. Two diabetologists independently evaluated the quality of information using a specially created scoring grid (range 0-52) based on acknowledged and published criteria with items relevant to general characteristics of the site and to information content. One hundred and twenty websites were selected but only 27 were included for analysis., Results: Agreement between the two raters was close for global score and site content but lower for site characteristics. Averaged global score ranged from 8 to 44. Only five sites were assessed as very advisable with a score higher than 39; in contrast 18 sites were judged as not advisable at all (score lower than 26)., Conclusion: This study, the first to be devoted to information about the diabetic foot on the Internet, clearly shows the variability and the general poor quality of information delivered by the great majority of French-speaking websites. Regulation organisms are urgently needed for checking and labelling public oriented health information in order to make the Internet a performing tool for patient information.

The aim of this prospective study was to evaluate the efficacy of the implementation of the International Consensus on the Diabetic Foot (ICDF) in the area of Pistoia (Tuscany, Italy), in terms of percentage of population screened, reduction of hospitalization, and reduction of lower extremity amputations. The study was carried out over a 5-year period (1999-2003) in a district general hospital covering a clearly defined and relatively static population. The implementation of ICDF was performed at district health care level, in collaboration with general practitioners, and at the hospital with the establishment of a multidisciplinary care team. The database for this study was extracted from the DRG Tuscany database, and the diabetes foot lesion data source was taken from the Data Elaboration Centre of the Health Care District of Pistoia, cross-checked with the clinical records of the Diabetes Unit. In the period of the study, there was an increase in both the total number of diabetic foot lesions observed and the number of patients with diabetes referred for evaluation to the Diabetes Unit of Pistoia. Following implementation, the total number of hospitalizations for diabetic foot lesions and the duration of clinical stay were reduced. The total incidence of amputations per 100,000 inhabitants decreased from 10.7 in 1999, to 10.1 in 2000, 2.7 in 2001, 6.3 in 2002 and 6.24 in 2003. In particular, while the incidence of major amputations decreased over time, the relative number of minor amputations increased in the first years, stabilizing at a higher rate in later years. Finally, while before 1999 most people from the Pistoia area were referred to various hospitals in Tuscany for diabetic foot problems, during the implementation period almost all were referred to the Diabetic Unit of Pistoia. This study shows the advantages of prospective data collection, demonstrating that the implementation of the International Consensus on the Diabetic Foot can improve foot care in diabetes.

A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.

Aims/hypothesis: Walking is recommended as an adjunct therapy to diet and medication in diabetic patients, with the aim of improving physical fitness, glycaemic control and body weight reduction. Therefore we evaluated walking activity on the basis of capacity, performance and potential risk of plantar injury in the diabetic population before it can be prescribed safely., Subjects, Materials and Methods: Twenty-three subjects with diabetic neuropathy (DMPN) were compared with 23 patients with current diabetic foot ulcers, 16 patients with partial foot amputations and 22 patients with trans-tibial amputations. The capacity for walking was measured using a total heart beat index (THBI). Gait velocity and average daily strides were measured to assess the performance of walking, and its impact on weight-bearing was studied using maximum peak pressure., Results: THBI increased (p<0.01) and gait velocity and daily stride count fell (p<0.001 for both) with progression of foot complications. The maximum peak pressures over the affected foot of patients with diabetic foot ulcers (p<0.05) and partial foot amputations (p<0.01) were higher than in the group with DMPN. On the contralateral side, the diabetic foot ulcer group showed higher maximum peak pressure over the total foot (p<0.05), and patients with partial foot amputations (p<0.01) and trans-tibial amputations (p<0.05) showed higher maximum peak pressure over the heel., Conclusions/interpretation: Walking capacity and performance decrease with progression of foot complications. Although walking is recommended to improve fitness, it cannot be prescribed in isolation, considering the increased risk of plantar injury. For essential walking we therefore recommend the use of protective footwear. Walking exercise should be supplemented by partial or non-weight-bearing exercises to improve physical fitness in diabetic populations.

Lower extremity amputations among persons with diabetes are generally preceded by neuropathic foot ulcerations. Healing of diabetic ulcerations in a timely manner is of central importance in any plan for amputation prevention. With sufficient vascular supply, appropriate débridement, and infection control, the primary mode of healing a diabetic neuropathic foot ulcer is pressure dispersion. The total contact cast has been deemed by many to be the gold standard in offloading; however, modification of a standard removable cast walker to ensure patient compliance may be as efficacious in healing diabetic foot ulcers as the total contact cast. Combining an effective, easy to use offloading device that ensures patient compliance with advanced wound healing modalities may form a formidable team in healing ulcers and potentially averting lower limb amputations.

Medical footwear provides solutions for structural or functional foot problems. Individuals with normal feet do not require medical footwear. In diabetic patients with neuropathy and foot deformity, the use of medical footwear protects the foot, reduces the plantar pressures and significantly reduces the rate of ulcers formation and amputations. Shoes have different designs, heights, and may be constructed of differing materials depending upon the nature of the needed corrections. Structurally, shoes can be viewed as consisting of a sole and an upper portion. Both these entities can be further sub-divided into components and shapes, each one providing a different corrective feature. Ordering medical footwear requires the same specificity as with the provision of medications. In Israel, shoes are provided by the Ministry of Health to patients according to specific criteria. The provision and quality control is conducted through a selected panel of doctors, chosen by the Lewis National Institute of Rehabilitation, and working in public hospitals.

A major goal of therapeutic footwear in patients with pain or those at risk for skin injury is to relieve focal loading under prominent metatarsal heads. One frequent approach is to place plugs of compliant material into the midsole of the shoe. This study investigated 36 plug designs, a combination of three materials, six geometries, and two placements using a two-dimensional (2D) finite element model. Realistic loading conditions were obtained from plantar pressures (PP) recorded during walking in five subjects who wore control midsoles manufactured using Microcell Puff. Measured peak pressures underneath the second metatarsal head were similar to the results of the control model. PP obtained from simulations with the plugs built into a firm midsole were compared to the simulation results of the control midsole. Large plugs (e.g. 40 mm width), made out of Microcell Puff Lite or Plastazote Medium, placed at peak pressure sites, resulted in highest reductions in peak pressures (18-28%). Smaller plugs benefited from tapering when placed at high pressure areas. Case studies were completed on a healthy male subject and a diabetic female patient to address the efficacy of a plug design favored by our simulations (pressure based placement, 40 x 20 mm, Plastazote Medium). Successful reductions of second metatarsal head pressures were observed with a mediolateral load redistribution that was not represented by our model. 2D computer simulations allowed systematic investigation of plug properties without the need for high volume experimentation on human subjects and established basic guidelines for plug selection. In particular, plugs that are placed based on plantar pressure measurements were proven to be more effective when compared to those positioned according to the projection of the bony landmark on the foot-shoe plantar contact area.

Background and Purpose: Although pressure-reducing interventions have been effective in the healing of neuropathic foot ulcers, these ulcers frequently recur in people with diabetes mellitus (DM). This case report illustrates how sudden changes in weight-bearing activity may have affected ulcer recurrence in a patient with DM and how the physical stress theory (PST) relates to ulcer recurrence for this patient., Case Description: The patient was a 66-year-old man with a history of DM, peripheral neuropathy, and recurrent plantar ulcers. His plantar ulcer healed after total contact casting., Outcome: Despite relatively low peak plantar pressure (9.3 N/cm(2)), the patient's ulcer recurred within 4 weeks of healing. Plantar pressure assessment and activity monitoring suggested that a rapid and sudden increase in weight-bearing activity (steps per day) contributed to cumulative plantar tissue stress that was 3.3 times higher on the day of ulcer recurrence than his average value. Although his cumulative plantar stress was high compared with his usual value, the cumulative value was similar to the amount of daily stress of individuals without a history of recurrent ulcers., Discussion: Within the context of the PST, rapid change in activity level may have an effect on cumulative stress and the risk of ulcer recurrence.

Objective: The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations., Research Design and Methods: We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing., Results: An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02)., Conclusions: Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds.

The abnormally elevated plantar pressures under the bony prominences of the diabetic foot (mainly under the medial metatarsal heads and calcaneus) were associated with intensified internal stresses in the deep soft tissues padding these bones. In this study, we tested changes in mechanical properties of muscular tissue after exposure to the internal stress levels typically developing under the first and second metatarsal heads in the load bearing diabetic foot (40-80 KPa). The gracilis muscles of anesthetized rats were subjected to constant external pressures of 35 and 70 KPa for 2 h, which caused average internal compression stresses of 40 and 80 KPa, respectively, within the living gracilis. The animals were then killed and the tangent elastic moduli of the harvested gracilis were measured in uniaxial tension at strains of 2.5%, 5% and 7.5%. Tangent moduli of gracilis muscles exposed to internal compression of 40-80 KPa in vivo ( n=6) were 1.6-fold stiffer ( p<0.05) than those of controls ( n=6). These abnormally stiff mechanical properties were incorporated into a finite element (FE) model of the plantar tissue under the second ray of the foot, and were shown to increase the magnitude of deep internal stresses and project elevated stresses to larger regions. Hence, the integration of animal model data with FE simulations indicates a mechanism of plantar tissue deterioration in the diabetic foot, where muscles exposed to critical stresses respond with increased stiffness which then further intensifies the deep plantar stresses. This suggests a new positive feedback mechanism for the diffusion of ulcers and the atrophy of intrinsic plantar muscles in the diabetic foot, where the injury spreads from deep muscles to the skin surface by an evolving mechanical stress wave.

In the daily routine of treating patients with diabetic neuropathic osteoarthropathy (DNOAP), their history often reveals a prolonged course of therapy caused in part by incorrect diagnosis but also by inadequate provision of orthopedic devices. A "classic" case is that of undetected osteoarthropathy, which is erroneously interpreted as osteomyelitis. Thus, subsequent to frustrating attempts at therapy and persistence of the clinical symptoms, patients are not infrequently "offered" the option of amputation, which is performed quite proximal to the osseous lesion to "ensure treatment success." The fact that major amputations lead to a statistically significant decrease of the patient's life span is usually not taken into consideration during the decision making process for amputation. Orthopedic surgical procedures to preserve the leg should be given precedence for the sake of maintaining quality of life just as orthopedic devices and orthopedic shoes should be preferred to retain mobility before amputation is indicated in patients with DNOAP. The cases reports presented here should encourage others to implement treatment concepts with the aim of avoiding unnecessary amputations.

Many people with diabetes develop foot ulcers which, in extreme cases, lead to digit amputation. A small trial of a new device that induces ankle dorsiflexion improved peripheral circulation and resulted in the complete healing of all ulcers.

Objective: To study the effects of custom-made insoles on plantar pressures and load redistribution in neuropathic diabetic patients with foot deformity., Design: Cross-sectional., Background: Although custom-made insoles are commonly prescribed to diabetic patients, little quantitative data on their mechanical action exists., Methods: Regional in-shoe peak pressures and force-time integrals were measured during walking in the feet of 20 neuropathic diabetic subjects with foot deformity who wore flat or custom-made insoles. Twenty-one feet with elevated risk for ulceration at the first metatarsal head were analysed. Load redistribution resulting from custom-made insoles was assessed using a new load-transfer algorithm., Results: Custom-made insoles significantly reduced peak pressures and force-time integrals in the heel and first metatarsal head regions; pressures and integrals were significantly increased in the medial midfoot region compared with flat insoles. Custom-made insoles successfully reduced pressures in and integrals at the first metatarsal head in 7/21 feet, were moderately successful in another seven, but failed in the remaining seven. Load transfer was greatest from the lateral heel to the medial midfoot regions., Conclusions: Custom-made insoles were more effective than flat insoles in off-loading the first metatarsal head region, but with considerable variability between individuals. Most off-loading occurred in the heel (not a region typically at risk). The load transfer algorithm effectively analyses custom-made-insole action., Relevance: Because similar insole modifications apparently exert different effects in different patients, a comprehensive evaluation of custom designs using in-shoe pressure measurement should ideally be conducted before dispensing insoles to diabetic patients with neuropathy and foot deformity., (Copyright 2004 Elsevier Ltd.)

Pedographic systems are now in use in many research centers and hospitals throughout the world. The platform system permits rapid and accurate static and dynamic measurement of the local pressure loading on the plantar surface of the foot, and also permits a functional assessment of the roll-over process in the bare foot. The in-shoe system employing an insole measures the pressure distribution within an orthopedic shoe and enables an accurate comparison of the loading situation before and after fitting. As an additional diagnostic tool, pedography improves preventive measures and the quality of the orthopedic treatment of the diabetic foot.

Objectives: To assess the impact of an educational training program we initiated in 1994 for GPs about diabetic foot ulcer (DFU) management, we compared the rate and level of lower limb amputation (LLA) in diabetic patients performed in our unit between two consecutive five-year periods, 1989-1993 and 1994-1998., Patients and Methods: During the first period, 132 patients with 163 lesions (9.2% of the total admissions for diabetes) were compared with 176 with 183 lesions (10.5%) during the second period. Patients' mean age was the same in both periods: 59.6 +/- 11.7 in 1989-1993 and 58.3 +/- 13.1 in 1994-1998 [Not statistically significant, NS]., Results: Patients age, sex ratio, type of diabetes and severity of the lesion (as assessed according to Wagner classification) were essentially the same during the two periods. Most of the foot lesions ( approximately 90%) were purely neuropathic or neuro-ischaemic, with no change in repartition between the two periods. Primary healing was 59.1% in the 1st period and 56.8% in the second. No change in minor and major amputation rate was observed between the 1st period (14.4 and 15.9%, respectively) and the second (11.4 and 16.5%, respectively). The in-hospital mortality rate was unchanged (9.1 vs 8.5%, NS), while the percentage of patients who left hospital against medical advice and dropped out of follow up increased from 1.5 to 6.8% (p<0.04). Mean length of hospitalisation was identical, about 43 days., Conclusions: In spite of implementing educational program for GPs, no improvement in the DFU management was noted as emphasised by absence of any significant change in amputation rate before (1st period) and after initiating the program (2nd period). These disappointing results can be explained by several factors: weakness of our educational program, lack of motivation from GPs, absence of a structured multidisciplinary prevention approach. The main problem, common to developing countries, remains the insufficiency of financial resources. Moreover, civil disturbances can make the problem more difficult to manage, as in Algeria since 1991.

In this review, the evidence for the role of footwear in causing, healing, and preventing foot ulceration in diabetic patients is discussed. The mechanisms of action of therapeutic footwear are elucidated, and an 'ideal' approach to footwear prescription is outlined. Finally, some future directions for 'intelligent' footwear are also presented., (Copyright 2004 John Wiley & Sons, Ltd.)

This paper presents details of the study undertaken to find the effects of foot sole hardness, thickness and footwear on walking-foot pressure distribution parameters (power ratio (PR)) in diabetic neuropathy. The foot sole hardness is characterized by Shore level. PR represents the ratio of high-frequency power to the total power in the power spectrum of the walking-foot pressure image distribution obtained from the optical pedobarograph. Spatial frequency distributions in the walking-foot pressure images were analysed to calculate the PR in each of the foot sole areas at different levels of foot sole sensation loss and mechanical and geometrical properties. The results show that the increase in PR in the upper foot sole Shore ranges (30-40) is 1.2-2.5 times the corresponding increase in lower Shore ranges (20-30) for some foot sole areas, implying a higher possibility of development of plantar ulcers when combined with deterioration of foot sole sensation. Plantar ulcers are found in feet with foot sole Shore values of 30, a sensation level of 45 mN and PR of 35; for Shore values of 40, sensation levels of 100 mN, with PR 52; and for Shore values above 40, sensation level > 100 mN with PR 58. Providing microcellular rubber insole footwear based on optimum hardness and thickness was found to be helpful in healing plantar ulcers in three to four weeks. Wearing preventive footwear for six months reduced hardness of the foot sole and PR values to near-normal values.

Aims: Diabetic patients with podopathy (diabetic foot syndrome) may need protective footwear, be it customized or industrially produced stock 'diabetic' shoes (SDS). The effectiveness of each type of 'diabetic' shoe needs to be proven clinically, e.g. in terms of prevention of foot ulceration. The following study assesses a new German SDS, the LucRo shoe, which consists of rocker-shaped walking sole, a standardized shock absorption insole, and soft uppers without stiff toe-caps. The LucRo SDS has been registered as a Medicinal Product according to the European Community Guideline 93/42/EC., Patients and Methods: A total of 92 high-risk diabetic patients (mean age 63 years, duration of diabetes 13 years) with healed foot ulcer were recruited prospectively over 31 months; 87 patients suffered from polyneuropathy, 24 patients had peripheral ischaemic vessel disease. One group of patients (n = 60) received the LucRo SDS and wore them, while the remaining patients (n = 32) did not receive the SDS and were forced to use their normal footwear. This allocation reflects the haphazard reimbursement policies of the individual patients' health insurance, and is in accordance with the current German legislation. The patients were followed up for up to 42 months until the first foot ulcer relapse, or the end of the study., Results: There were no differences between the groups concerning age, sex, type and duration of diabetes, prevalence of polyneuropathy and peripheral ischaemic vessel disease, frequency of foot care and mortality rate. The first year annual rate of foot ulcer relapse was significantly different between the groups: 60% without SDS vs. 15% with SDS. The overall cumulative ulcer-free survival was significantly greater with SDS (P < 0.0001, log rank test)., Conclusion: The LucRo stock 'diabetic' shoe appears effective in the prevention of foot re-ulceration in high-risk patients with diabetic podopathy.

Objective: This study tests the hypothesis that Medicare beneficiaries at high risk of foot complications who are mailed a motivational brochure describing the Medicare diabetes-related therapeutic footwear benefit will increase their therapeutic footwear-related Medicare claims., Research Design and Methods: In this quasi-experimental study, a motivational brochure was mailed in the summer of 1997 to 5,872 Medicare beneficiaries in Washington, Alaska, and Idaho who were identified as being at high risk for foot-related claims on the basis of their prior Medicare claims history. Beneficiaries were identified through footwear claims made in these states-and also in three comparison states (Oregon, Montana, and Wyoming)-during the 18 months before and after the mailing. Linear regression was used to compare the number of persons making claims in the intervention states with the comparison states before, at the time of, and after the mailing., Results: Before the intervention, the number of persons making claims was increasing in the non-intervention states and decreasing in the intervention states. During the first month after the intervention mailing, the number of persons making claims remained nearly the same in non-intervention states, but increased 13 persons per month in intervention states (95% CI 3.5-11 persons/month). After the intervention, the number of persons making claims continued to increase similarly in both intervention and non-intervention states., Conclusions: Mailed motivational brochures were associated with an increase in the number of persons making therapeutic footwear claims. Randomized trials should confirm these findings.

The Villiers-Saint-Denis Hospital in France specializes in the rehabilitation of and fitting of orthoses for lower-limb amputees, who frequently have diabetes mellitus. The percentage of partial-foot amputations has increased relative to the percentage of transtibial or transfemoral amputations. This article describes a complete range of orthoses and prostheses, adapted to each patient, that allow recovery of the standing position, gait ability, and physical activity.

Until now there are only few studies with small samples dealing with psychosocial aspects of patients with diabetic foot ulcer. The main interest concerns the quality of life of these patients. By reviewing the literature and our own clinical experience, the influence of psychic comorbidity on the treatment process will be demonstrated. Mobility and hospitalization are also related to problems of coping with diabetic foot ulcer and psychosocial problems (e.g., job, partnership, and social support). Therefore, disease management programs for patients with diabetes mellitus types I and II should include psychosomatic-psychotherapeutic diagnostics. The necessity for interdisciplinary work between orthopedics and psychosomatics is discussed.

The objective of this study was to determine in healthy individuals whether the Bledsoe Diabetic Conformer Boot reduces plantar pressures as well as a fiberglass total contact cast. Eighteen normal subjects, without any prior foot or ankle problems, were recruited for this study. Plantar pressures were measured using the Novel Pedar in-shoe pressure measurement system. The results of this study demonstrate that in individuals without foot deformities, the Bledsoe Diabetic Conformer Boot performs as well as, and in many parameters, even better than a fiberglass total contact cast with respect to reducing the forces and pressures on the plantar surface of the foot.

This study developed and tested the Foot Care Confidence Scale (FCCS), an instrument designed to measure the confidence (self-efficacy) diabetics have in performing foot self care. Content validity was assessed using Lynn's (1986) Content Validity Index (CVI) with a total of 100% content validity (Sloan, 1993). The FCCS was administered to four persons with diabetes (Sloan, 1994) and pilot tested with 41 healthy older adults (Wills & Sloan, 1995). Based on the feedback from the pilot testing and CVI panel of judges, as well as additional literature review, the instrument was revised. A study involving 122 community-dwelling older adults with a diagnosis of diabetes for five or more years was conducted. The FCCS had a Cronbach's alpha of 0.92. Factor analysis revealed that all 12 items loaded on one factor and all 12 items are needed to measure confidence to care for one's feet. The FCCS is a practical instrument for use in many settings, especially where time constraints exist. It may assist the nurse in evaluating and improving outcomes of self care of the feet of persons with diabetes mellitus.

Objective: To report the efficacy of injected liquid silicone (ILS) in the foot at 2 years after administration., Design: Randomized controlled trial., Setting: Diabetic foot clinic in the United Kingdom., Participants: Twenty-eight diabetic neuropathic patients, randomized into an active treatment group (n=14) and a placebo group (n=14)., Intervention: Participants were given either 6 injections of 0.2mL of liquid silicone (silicone group) or equal volumes of saline (placebo group) under metatarsal head sites with callus., Main Outcome Measures: Plantar tissue thickness and plantar pressures were measured at 3, 6, 12, and 24 months postinjection., Results: At 12 months, the plantar tissue thickness in the silicone group had increased by a mean 1.6+/-0.9mm (P=.001), and remained increased at 24 months (1.1+/-0.7mm, P=.003). Peak plantar pressure in the silicone group was reduced at 12 months (-165.0+/-253.5kPa, P=.03), but not at 24 months. There was no change in tissue thickness or peak plantar pressure in the placebo group at 12 and 24 months. The reduction in the pressure time integral (PTI) in the silicone group did not reach significance at 12 months (-.71+/-1.17kPa/s, P=.055). Although PTI returned to baseline at 24 months for the silicone group, it was significantly increased in the placebo group (.64+/-.37kPa/s, P=.043), suggesting that silicone may still exhibit some pressure-reducing properties after 24 months., Conclusions: The results indicate that at 24 months postinjection the cushioning properties of ILS have reduced, suggesting that booster injections may be required in certain patients., (Copyright 2002 by the American Congress of Rehabilitation Medicine and the American Academy of physical Medicine and Rehabilitation)

The relationship between repetitive trauma and propensity for ulceration and ulcer healing is unknown in part because of the lack of accurate information on activity level. The Step Activity Monitor (SAM) is a newly designed accelerometer to record activity level, but its accuracy is questionable. The purpose of this study was to determine the accuracy of the SAM under varying footwear and walking surface conditions. Ten healthy subjects consented to walk over 530 m of flat ground and up and down two flights of stairs, while wearing an athletic shoe or a fiberglass total contact cast (TCC). The accelerometer, programmed for a subject's cadence and leg motion, was secured to the distal, lateral aspect of the right lower leg. Two observers using hand-held digital counters followed the subject and recorded steps taken with the right leg on all walking surfaces. With the use of a repeated measures analysis of variance (ANOVA), the SAM and hand-held digital counters similarly recorded steps taken, regardless of walking surface condition. While the SAM was highly accurate (94 to 96 percent), the percent error was greater (p = 0.007) for the stair-climbing condition with the use of the TCC because of two subjects using a step-to-gait pattern. Overall, the SAM is an accurate accelerometer that will accurately record activity level, even with the application of a TCC. However, its accuracy may vary with deviations from a normal gait pattern.

Objectives: To determine the reliability of using 3-dimensional (3D) spiral x-ray computed tomography (SXCT) imaging methods to measure anatomic foot structure and to test the validity of using a loading device to simulate walking pressures on the plantar foot during SXCT examination., Design: Nonrandomized control trial of consecutive patients with complete data compared with age-matched controls., Setting: A clinical SXCT scanner and physical therapy laboratory in a local hospital., Participants: Eight subjects with diabetes and a history of forefoot ulcers and 8 control subjects., Interventions: SXCT imaging and plantar pressure analysis were used to acquire 3D volumetric structure and pressure data of the foot during 4 foot positions, 2 weight bearing and 2 non-weight bearing., Main Outcome Measures: Differences between repeated SXCT measures of foot structure. Comparisons of plantar foot pressure. Foot structure measurements. Methods for measuring the bony angles and soft-tissue thickness were developed and reliability tests were performed., Results: There was essentially no bias (<+/-0.5mm or +/-0.5 degrees ) and a high degree of reliability (81% of the measures had a reliability <2.0mm or 2 degrees ) when measuring foot structures. Correlations of pressure measures collected on the loading device compared with those collected during walking were (mean +/- standard deviation) r =.66 +/-.06. The percentage agreement between the pressures collected on the loading device and during walking was 91.1% +/- 4.7%., Conclusion: Reliability of anatomic foot structure measurements and validity of plantar loading during visualization were good. These methods may be used to determine structural differences between diabetic and healthy feet and to evaluate how these differences relate to plantar pressures., (Copyright 2002 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)

Multiple offloading modalities are currently used in the management of diabetic plantar foot ulcerations. A relatively new device, the Rocker Insole, was tested for its ability to relieve plantar forefoot pressures when inserted into a surgical boot as compared to a patient's customary footwear and the surgical boot alone. The Rocker Insole significantly reduced forefoot pressures by 48% when worn inside the surgical boot. Mean peak pressures unexpectedly increased 12% when the surgical boot was worn alone. This preliminary investigation suggests that when worn in conjunction with a surgical boot, the Rocker Insole can effectively offload plantar forefoot pressures and may be useful in the management of plantar metatarsal ulcerations.

This review describes a decision pathway for the conservative management of foot problems in persons with diabetes mellitus. The decision pathway was developed by the Louisiana State University Health Sciences Center Diabetes Foot Program as part of the Statewide Diabetes Disease Management Initiative to standardize foot care in a medically underserved population. The pathway describes the prevention and/or management of foot problems through 5 clinical subpathways: injury prevention, warm swollen foot, ulcer, osteomyelitis, and remodeling. The pathway provides physiatrists and other rehabilitation practitioners with a framework to evaluate and manage neuropathic foot problems in a multidisciplinary setting., (Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)

Results of complex treatment of 121 patients with syndrome of diabetic foot, complicated by purulent-necrotic affection of tissues, were analyzed. Individually differentiated approach in the choice of surgical tactics had permitted to improve the result of treatment.

Experience of treatment of 2524 patients with diabetes mellitus (DM) for the 1990-2001 yrs period was summarized. Of all the patients 48-52% are presenting the citizens of Darnitskiy and Kharkivskiy regions of city of Kyiv. For the 1990-1994 yrs period general lethality had constituted 7.5-9.1%, postoperative mortality--9.2-13.5%, while after 1996--4.3-1.9 and 5.4-1.1% accordingly. Improvement of results of treatment was promoted by conversion in 1996 to conduction of operative interventions using spinal or epidural anesthesia. From 2000 we are planning performance of two-, three- or multistage treatment of patients because there exists possibility to preserve the foot, using several stages to excise nonviable tissues and to perform plastic operations. Right from the moment when conversion to multistaged operations happened, new demands occurred for quality of local measures of struggle against infection and for application of technology for preservation of viability in the skin-free foot tissues. Analysis of the case records of 62 patients with DM, to whom in other medical institutions operation for purulent-necrotic affection of the foot was performed, witnesses the necessity of spreading of the experience of the specialized division work among surgeons and endocrinologists.

Three-year experience of management and treatment of 3553 patients with diabetes mellitus (DM), including 500--insulindependent and 3053--insulinindependent cases, was summarized. Divisional endocrinologist is choosing patients with DM and high risk of the diabetic foot syndrome (DFS) or its signs. In presence of risk factors for DFS occurrence the patient is trained to care of foot and petty surgical manipulations are performed: to cut off toenails, treatment of superficial affection of skin and fungous affection of skin, determination of the foot setting, correcting insole to fit footwear if necessary. If all kinds of sensitivity are reduced on the foot in the absence of its deformity and ulcer the patient is recommended once a year to treat in endocrinological stationary and to consult surgeon in Centre of treatment of DM complications. If the foot blood supply is disordered, ulcer occurrs the patient is referred to surgeon. In 2132 (60%) patients risk factors or DFS signs were revealed. Surgical treatment for purulent-necrotic affection was conducted in 61 patients (2.9% of the patients number with risk factors of the foot affection), including intervention on the foot--in 50 (2.3%), high amputation of lower extremity--in 11 (0.6%).

Objective: To test the accuracy and precision of computed tomography (CT) imaging for describing the 3-dimensional structure of the foot in patients with diabetes mellitus and peripheral neuropathy., Design: Experimental, test-retest., Setting: Clinical CT scanner at a local hospital., Specimens: Two tissue-equivalent phantoms and 6 cadaver feet., Main Outcome Measures: Measurements taken from CT data of phantoms and cadaver feet were compared with physical (caliper) measurements. The feasibility of creating a computer-aided design/rapid prototyping 3-dimensional model from CT data was assessed by using 1 cadaver foot., Results: No bias was found for phantom or cadaver CT measurements compared with caliper measurements. The mean difference between repeat scans of cadaver feet (1 observer) was 0.1 +/- 0.8 mm and between observers, 0.4 +/- 0.8 mm. Comparing caliper measurements of the rapid prototype model and actual foot measurements revealed an error of 0.3 +/- 0.4 mm., Conclusion: CT-based 3-dimensional imaging produced accurate and precise foot measurements, enabling description of internal and external structures. This capability will be coupled with plantar pressure measurements to improve our understanding and treatment of foot ulcers in people with diabetes., (Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)

To reduce the strain on the middle and forefoot in postoperative and posttraumatic care, we developed a new shoe. It is applied as part of treatment following skeletal or soft tissue surgery in this region and in treatment of the diabetic foot (types I and II). Pedographically, we found the vertex of the roll-off process located at the base of the fifth metatarsal bone, meaning that the foot starts to roll-off at this point while walking. The movement was recorded by a pedobarograph bearing full weight and with the use of one crutch in comparison to the roll-off process in a regular shoe. Results show a reduction of the plantar strain on the forefoot of 70% and of 62% on the Chopart joint while bearing full weight. The use of (forearm-) crutches reduces strain further. The new design of the sole enables the (podiatric) patient to stand and walk in a well-balanced fashion. Since immobilisation of the calf is avoided and muscular function is increased, the risk of thromboembolic complications can be minimized. Four different sizes of the "Strain Minimizing Shoe", including seven modular insoles are available, providing a wide range of individually adapted shoe applications for the patient's foot.

Lesions to the diabetic foot have various causes. However, there is broad consensus that excessive plantar pressure plays a major role in the chain of events leading to ulcerations and gangrenes. During walking, on the other hand, peak values of plantar pressure are likely to increase with velocity even in therapeutic shoes. Therefore, the question arises whether a moderate velocity should be recommended to diabetic patients to reduce the risk of foot lesions. In this study, two velocities were compared for different types of therapeutic footwear. The velocities selected were considered moderate (0.7 m/s) and normal (1.3 m/s) for diabetic patients. A specially designed mathematical algorithm (velocity normalization) provided the pressure distributions from a common set of measurements: seven trials at different velocities for each subject and each type of footwear. Ten test subjects with healthy feet were studied. The shoes were ready-made and all had a midfoot rocker. The following four conditions were tested: flexible or rigid outsole respectively in combination with a flat insole or molded foot bed respectively. Pressure distribution measurements were performed with the Pedar in-shoe system, and the Pedar software package was used for analysis. The foot was divided into six regions: first toe, second to fifth toes, metatarsal region, medial midfoot, lateral midfoot, and heel. Only peak pressures were taken into account. Gait velocity was found to have an effect on plantar pressure distribution, mainly in the toes and heel region. Peak pressure in the heels increased significantly by about 20%. In the toe region, the increase was about the same, but was not statistically significant. At a higher velocity, pressure even slightly decreased in the midfoot region. The percentage variation was similar for all four conditions. Thus, walking slowly prevented the foot from high peak pressures, and the combination of rigid outsole and molded foot bed was best suited for both slow and higher velocities.