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Aim: To compare the effectiveness of preventive interventions in reducing reccurrent diabetic foot ulcers. Meta-analysis (MA) was conducted to address clinical questions on this topic of the Italian guidelines on diabetic foot. Methods: This MA includes randomized controlled trials evaluating the effectiveness of various preventive interventions, namely: treatment of pre-ulcerative foot lesions, structured educational programs, psychological interventions and the use of therapeutic footwear to relieve plantar pressure in people with diabetes mellitus and a history of previous ulcers. Results: A total of 731 studies were identified and 14 were considered eligible for the analysis. We found that treatments of pre-ulcerative foot lesions did not provide any statistically significant effects (MH-OR: 0.84 [0.31, 2.33], p = 0.74, I2 = 38%). Conversely, structured educational programs were associated with a trend toward reduction of ulcer recurrence risk (MH-OR: 0.13 [0.01, 1.64], p = 0.10, I2 = 88%). No randomized controlled studies assessing the efficacy of psychological interventions have been retrieved. The use of therapeutic footwears can effectively reduce the risk of reulceration in diabetic patients with an history of previous DFU, in particular prefabricated rigid-soled therapeutic footwears showed a significant reduction of the risk of ulcer recurrence in comparison with semirigid soles (MH-OR: 0.17 [0.05, 0.57], p = 0.004). Conclusions: The study provides low-certainty evidence that, among preventive strategies in patients with previous DFU, rigid-sole therapeutic footwear and structured education programs are capable of reducing the risk of foot re-ulceration. [ABSTRACT FROM AUTHOR]

This study aimed to explore the association between metabolic‐associated fatty liver disease (MAFLD) and ulcer recurrence risk in patients with diabetic foot ulcers (DFUs) through an ambispective longitudinal cohort. From December 2013 to December 2022, a total of 482 inpatients with DFUs (PEDIS grade 3 and above with a severe infection) were eligible for inclusion in this study. This was an ambispective longitudinal cohort study. All participants were followed up every 6 months for 9 years with a median of 36 months. According to whether having MAFLD or not, all subjects were placed into two groups: non‐MAFLD (n = 351) and MAFLD (n = 131). The association between MAFLD and ulcer recurrence in patients with DFUs was then evaluated through multivariate Cox regression analysis, stratified analyses and Kaplan–Meier survival analysis. Throughout the follow‐up period, out of 482 subjects with DFUs, 68 had ulcer recurrence (14.1%). Three Cox regression models were established for data analyses. In the model I (unadjusted), MAFLD was significantly associated with the ulcer recurrence rate in patients with DFUs (HR = 1.79; 95% CI = 1.097–2.92; p = 0.02). Model II (adjusted model I with gender and age) (HR = 1.781; 95% CI = 1.09–2.912; p = 0.021) and model III (adjusted model II with CVD, duration of diabetes and Cr.) (HR = 1.743; 95% CI = 1.065–2.855; p = 0.027) also showed that MAFLD was significantly related to the ulcer recurrence risk in patients with DFUs, respectively. Stratified analysis indicated that subjects aged ≥60 had a greater risk of ulcer recurrence in MAFLD than in non‐MAFLD (HR = 2.31; 95% CI = 1.268–4.206; p = 0.006). Kaplan–Meier survival curve analysis showed that ulcer recurrence rate had a significant association with MAFLD (log‐rank, p = 0.018). This study indicated a close association between ulcer recurrence risk and MAFLD in patients with DFUs, especially in the elderly (aged ≥60). Therefore, special attention should be paid to the elderly with both DFUs and MAFLD because they have a higher ulcer recurrence rate than other general populations in routine clinical practice. [ABSTRACT FROM AUTHOR]

An impaired healing response underlies diabetic foot wound chronicity, frequently translating to amputation, disability, and mortality. Diabetics suffer from underappreciated episodes of post-epithelization ulcer recurrence. Recurrence epidemiological data are alarmingly high, so the ulcer is considered in "remission" and not healed from the time it remains epithelialized. Recurrence may result from the combined effects of behavioral and endogenous biological factors. Although the damaging role of behavioral, clinical predisposing factors is undebatable, it still remains elusive in the identification of endogenous biological culprits that may prime the residual scar tissue for recurrence. Furthermore, the event of ulcer recurrence still waits for the identification of a molecular predictor. We propose that ulcer recurrence is deeply impinged by chronic hyperglycemia and its downstream biological effectors, which originate epigenetic drivers that enforce abnormal pathologic phenotypes to dermal fibroblasts and keratinocytes as memory cells. Hyperglycemia-derived cytotoxic reactants accumulate and modify dermal proteins, reduce scar tissue mechanical tolerance, and disrupt fibroblast-secretory activity. Accordingly, the combination of epigenetic and local and systemic cytotoxic signalers induce the onset of "at-risk phenotypes" such as premature skin cell aging, dysmetabolism, inflammatory, pro-degradative, and oxidative programs that may ultimately converge to scar cell demise. Post-epithelialization recurrence rate data are missing in clinical studies of reputed ulcer healing therapies during follow-up periods. Intra-ulcer infiltration of epidermal growth factor exhibits the most consistent remission data with the lowest recurrences during 12-month follow-up. Recurrence data should be regarded as a valuable clinical endpoint during the investigational period for each emergent healing candidate. [ABSTRACT FROM AUTHOR]

Background: Geraniol (GE) is dietary acyclic monoterpene alcohol found in essential oils from aromatic plants with therapeutic value against gastric ulcers already described. Hypothesis/Purpose: To assess whether oral GE accelerates gastric healing or prevents ulcer recurrence, and to evaluate the hypothesis that GE promotes antiulcer effects by the inhaled route and that promotes changes in the behavior of ulcerated rodents. Methods: Gastric healing effects, underlining mechanisms, and behavioral changes were measured in80% acetic acid-induced gastric ulcer model in rats receiving GE by oral (30 mg/kg) or inhaled route (1 mg/L of air/min); whereas the effects of GE to avoid ulcer recurrence was evaluated in mice submitted to 10% acetic acid plus IL-1β ulcer. Results: GE administered by both routes accelerates gastric healing, increasing mucin and GSH levels, CAT, and GST activities, and reducing MPO activity. Moreover, oral, and inhaled GE minimized ulcer recurrence reducing gastric TNF and IL-6 levels and preserving mucin levels. Interestingly, the inhalation or oral intake of GE promotes anxiolytic-like effects in ulcerated rats. Conclusion: Data altogether suggest that the GE accelerates gastric healing through the strengthening of protective factors of the gastric mucosa, promoting a quality healing that reduces the recurrence of the lesion. Besides, the anxiolytic-like effect of GE may also contribute to its gastric healing action since anxiety is recognized as one of the etiologic agents of ulcers. [ABSTRACT FROM AUTHOR]

Background: The health-related quality of life (HRQoL) of people with diabetes-related foot complications has been increasingly reported, mostly from studies of people with a foot ulcer. The aim of this study was to assess HRQoL and determine factors associated with HRQoL in people with diabetes at high risk of foot ulceration. Methods: In all, 304 participants enrolled in the Diabetic Foot Temperature Trial (DIATEMP) were included in the cross-sectional analysis. HRQoL was measured by the RAND® 36-Item Short Form Health Survey (SF-36) at baseline. Potential factors associated with HRQoL were analysed using multiple linear regression analyses for the eight domains of the SF-36. Results: Participants were predominantly male (72%), mean age 64.6 (±10.5) years, 77% type 2 diabetes and mean duration of diabetes 20 (±14) years. Mean SF-36 domain scores for the General Health (49.2 ± 20.1), Role Physical (50.9 ± 44.7), Physical Function (58.5 ± 27.9) and Vitality domains (59.8 ± 21.6) were lower compared to the Mental Health (78.4 ± 18.0), Social Functioning (75.3 ± 24.2), Role Emotional (73.5 ± 38.9) and Bodily Pain (67.0 ± 27.0) domains. HRQoL was lower than Dutch population-based and general diabetes samples, but higher than in samples with an ulcer. Use of a walking aid was associated with lower HRQoL across all 8 SF-36 domains (β range − 0.20 to − 0.50), non-Caucasian descent was associated with lower HRQoL in 5 domains (β range − 0.13 to − 0.17). Not working, higher BMI and younger age were associated with lower HRQoL in 3 domains. Conclusions: People at high risk of diabetes-related foot ulceration have reduced HRQoL that varies across domains, with the physical domains most affected. Assessing mobility, ethnicity, BMI and job status may be useful in daily practice to screen for people who might benefit from interventions targeting HRQoL. Trial registration: Netherlands Trial Registration: NTR5403. Registered on 8 September 2015. [ABSTRACT FROM AUTHOR]

Multiple clinical trials and real‐world studies have demonstrated accelerated healing in diabetic foot ulcers (DFU) treated with advanced modalities, such as topical oxygen therapy (TOT). In addition to healing, the durability of wound closure is a crucial long‐term endpoint for DFU clinical trials: an advanced treatment that does not confer a reasonable ulcer‐free period will have limited clinical benefit and modest economic value. Preclinical studies suggest that DFUs receiving topical oxygen therapy will experience improved quality of healing: increased collagen deposition and angiogenesis. It is postulated that these changes will translate into a more long‐lasting closure for ulcers treated with TOT and SOC compared to ulcers treated with SOC alone. At the conclusion of a recently completed randomised controlled DFU clinical trial evaluating the efficacy of TOT and SOC compared to SOC alone, patients with healed ulcers were asked to enrol in a long‐term follow‐up study. Healed patients completed four questionnaires through text messages or phone calls within 1‐year post completion of the trial. Twenty‐nine patients consented to participate in the long‐term follow‐up trial (17 TOT/SOC and 12 SOC). Only seven subjects were lost to follow up (5 TOT and 2 SOC). This is a surprisingly low number when factoring in the disruption caused by the COVID‐19 pandemic that continued throughout the entire follow‐up period. In the remaining patients, 85% of the TOT patients and 60% of the SOC remained healed at 1 year. There was one major amputation, which occurred in an SOC‐treated patient. The numbers in the long‐term follow‐up were too small to reach statistical significance; however, there is a strong trend toward more durable closure in ulcers treated with TOT. [ABSTRACT FROM AUTHOR]

Free flap transfer is a well-established treatment for foot reconstruction in patients with chronic limb-threatening ischemia (CLTI) and can achieve prolonged amputation-free survival. However, reports on ulcer recurrence after free flap transfer are scarce, with most focusing on trauma patients. Therefore, we retrospectively reviewed patients with CLTI who underwent free flap reconstruction at our institution over a 17-year period. Patient characteristics, ulcer recurrence rates, activity level, and variables associated with ulcer recurrence were investigated in patients who met the following criteria: successful reconstructive surgery, complete wound healing, and at least 1 year of follow-up. Free flap foot reconstruction was performed in 42 patients (92.9% male, 7.1% female; mean age 57.1 years, range 37-81 years). Among them, 39 patients (92.9%) had diabetes mellitus, 15 (35.7%) had critical limb ischemia, and 15 (35.7%) had end-stage renal disease/hemodialysis. Mean postoperative follow-up was 60.5 (range 12.0-208.0) months. The 5-year primary ulcer recurrence-free survival rate was 48.7%. High activity level and selection of the posterior tibial artery as the recipient artery were significantly associated with ulcer recurrence [hazard ratio, 3.59 and 9.81; P  = .046 and P  < .001, respectively]. Activity levels were not significantly different before and 1 year after surgery. In conclusion, survival analysis revealed that ulcer recurrence is most likely to occur within the first 2 years after surgery. Although recurrence occurred in approximately half of the patients, most patients maintained activity levels comparable to their preoperative levels., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background/purposes Diabetic foot is a major health problem affecting a large portion of diabetic patients and needs multidisciplinary teamwork to achieve satisfactory results. Revascularization, surgical debridement, and soft tissue reconstruction are essential for complete cure. Split-thickness skin graft (STSG) is a widely accepted method for soft tissue coverage of open wounds; this technique has a significant role in burn wounds and plastic surgery reconstruction. Its use in the treatment of chronic diabetic foot ulcers is challenged by the high failure rates, particularly when used to cover plantar ulcers. Other reconstructive options are costly, demanding, and, therefore, not preferable in the setting of comorbid high-risk patients. This study assesses whether the addition of site-specific offloading would help prevent recurrent ulceration following the application of STSGs for the treatment of diabetic foot plantar ulcers. Patients and methods Adult patients with diabetic foot infection who underwent surgical debridement, plantar wound reconstruction with STSG, site-specific offloading, and completed a clinical follow-up of at least 1 year were selected for analysis. Results Forty-two patients underwent STSG. Out of them 38 (90.0%) patients had infection and 23 (54.8%) had gangrene. Successful revascularization was done in 27 (64.3%) patients before enrollment. Debridement and toe amputation were done in 16 (38.1%) and 17 (40.5%) patients, respectively. Transmetatarsal amputation was done in nine (21.4%) patients. The average wound size was 21 cm2 and ranged from 6 to 120 cm2. The median time to complete wound healing was 6 weeks. Thirty-four (81.0%) patients had complete healing by 2 months. We found a statistically significant relationship between compliance to offloading and healing at 3, 4, and 5 months of follow-up (P=0.001, 0.02, 0.02, respectively). During the 1-year follow-up period, 13 (30.95%) patients experienced ulcer recurrence. Ulcer recurrence was significantly higher among patients who were noncompliant to offloading (58.82 vs. 12%, P=0.0021). Conclusions STSG together with site-specific offloading can be considered a reliable option for achieving accelerated wound healing and prevention of recurrence in diabetic foot patients after proper wound preparation. [ABSTRACT FROM AUTHOR]

Abstract Background Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is designed to influence multifaceted mechanisms of foot ulcer occurrence. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU). Methods/design The trial is designed as a two arms, parallel-group, open-label randomized controlled intervention study. The Log-rank Test was used for calculating sample size based on the latest national multicenter survey data of DFU in China. Three hundred and twenty participants will be recruited from the Diabetic Foot Care Center, West China Hospital, Sichuan University. Adults with diabetic peripheral neuropathy, healed foot ulceration in the 3 months prior to randomization, and aged ≥18 years, will be recruited. Participants will be randomized to receive novel diabetic therapeutic footwear (n = 160) or their own footwear (n = 160). The primary outcome will be the incidence of ulcer recurrence. The secondary outcome will be measurements of barefoot dynamic plantar pressures, the influence of footwear adherence on ulcer recurrence, and the incidence of cardiovascular events. Assessment visits and data collection will be obtained at baseline, 1, 3, 6, 9, and 12 months. The intention-to-treat principle will be applied. A cox regression model will be used to calculate the hazard ratio for the incidence of ulcer recurrence. The change of barefoot dynamic plantar pressures will be assessed using repeated measures ANOVA. The study protocol has been approved by the Ethics Committee of The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2019(96)). Discussion This clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients. Trial registration Chinese Clinical Trial Registry ChiCTR1900025538 . Registered on 31 August 2019.

Abstract Background The health‐related quality of life (HRQoL) of people with diabetes‐related foot complications has been increasingly reported, mostly from studies of people with a foot ulcer. The aim of this study was to assess HRQoL and determine factors associated with HRQoL in people with diabetes at high risk of foot ulceration. Methods In all, 304 participants enrolled in the Diabetic Foot Temperature Trial (DIATEMP) were included in the cross‐sectional analysis. HRQoL was measured by the RAND® 36‐Item Short Form Health Survey (SF‐36) at baseline. Potential factors associated with HRQoL were analysed using multiple linear regression analyses for the eight domains of the SF‐36. Results Participants were predominantly male (72%), mean age 64.6 (±10.5) years, 77% type 2 diabetes and mean duration of diabetes 20 (±14) years. Mean SF‐36 domain scores for the General Health (49.2 ± 20.1), Role Physical (50.9 ± 44.7), Physical Function (58.5 ± 27.9) and Vitality domains (59.8 ± 21.6) were lower compared to the Mental Health (78.4 ± 18.0), Social Functioning (75.3 ± 24.2), Role Emotional (73.5 ± 38.9) and Bodily Pain (67.0 ± 27.0) domains. HRQoL was lower than Dutch population‐based and general diabetes samples, but higher than in samples with an ulcer. Use of a walking aid was associated with lower HRQoL across all 8 SF‐36 domains (β range − 0.20 to − 0.50), non‐Caucasian descent was associated with lower HRQoL in 5 domains (β range − 0.13 to − 0.17). Not working, higher BMI and younger age were associated with lower HRQoL in 3 domains. Conclusions People at high risk of diabetes‐related foot ulceration have reduced HRQoL that varies across domains, with the physical domains most affected. Assessing mobility, ethnicity, BMI and job status may be useful in daily practice to screen for people who might benefit from interventions targeting HRQoL. Trial registration Netherlands Trial Registration: NTR5403. Registered on 8 September 2015.

Introduction: Internal partial forefoot amputation (IPFA) is a treatment option for osteomyelitis and refractory and recurrent chronic ulcers of the forefoot. The aim of our study was to assess the healing rate of chronic ulcers, risk of ulcer recurrence at the same area or re-ulceration at a different area and revision rate in patients treated with IPFA. Materials and methods: All patients who underwent IPFA of a phalanx and/or metatarsal head and/or sesamoids at our institution because of chronic ulceration of the forefoot and/or osteomyelitis from 2004 to 2014 were included. Information about patient characteristics, ulcer healing, new ulcer occurrence, and revision surgery were collected. Kaplan–Meier survival curves were plotted for new ulcer occurrence and revision surgery. Results: A total of 102 patients were included (108 operated feet). 55.6% of our patients had diabetes. In 44 cases, an IPFA of a phalanx was performed, in 60 cases a metatarsal head resection and in 4 cases an isolated resection of sesamoids. The mean follow-up was 40.9 months. 91.2% of ulcers healed after a mean period of 1.3 months. In 56 feet (51.9%), a new ulcer occurred: 11 feet (10.2%) had an ulcer in the same area as initially (= ulcer recurrence), in 45 feet (41.7%) the ulcer was localized elsewhere (= re-ulceration). Revision surgery was necessary in 39 feet (36.1%). Only one major amputation and five complete transmetatarsal forefoot amputations were necessary during the follow-up period. Thus, the major amputation rate was 0.9%, and the minor amputation rate on the same ray was 13.9%. Conclusions: IPFA is a valuable treatment of chronic ulcers of the forefoot. However, new ulceration is a frequent event following this type of surgery. Our results are consistent with the reported re-ulceration rate after conservative treatment of diabetic foot ulcers. The number of major amputations is low after IPFA. Level of evidence: Retrospective Case Series Study (Level IV). [ABSTRACT FROM AUTHOR]

Background: Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is designed to influence multifaceted mechanisms of foot ulcer occurrence. The aim of this study is to examine the effect of the optimally designed therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulcers (DFU).Methods/design: The trial is designed as a two arms, parallel-group, open-label randomized controlled intervention study. The Log-rank Test was used for calculating sample size based on the latest national multicenter survey data of DFU in China. Three hundred and twenty participants will be recruited from the Diabetic Foot Care Center, West China Hospital, Sichuan University. Adults with diabetic peripheral neuropathy, healed foot ulceration in the 3 months prior to randomization, and aged ≥18 years, will be recruited. Participants will be randomized to receive novel diabetic therapeutic footwear (n = 160) or their own footwear (n = 160). The primary outcome will be the incidence of ulcer recurrence. The secondary outcome will be measurements of barefoot dynamic plantar pressures, the influence of footwear adherence on ulcer recurrence, and the incidence of cardiovascular events. Assessment visits and data collection will be obtained at baseline, 1, 3, 6, 9, and 12 months. The intention-to-treat principle will be applied. A cox regression model will be used to calculate the hazard ratio for the incidence of ulcer recurrence. The change of barefoot dynamic plantar pressures will be assessed using repeated measures ANOVA. The study protocol has been approved by the Ethics Committee of The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2019(96)).Discussion: This clinical trial will give information on the ability of novel diabetic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration. If the optimally designed therapeutic footwear does work well, the findings will contribute to the development of innovative treatment devices for preventing foot ulcer recurrence in high-risk patients.Trial Registration: Chinese Clinical Trial Registry ChiCTR1900025538 . Registered on 31 August 2019. [ABSTRACT FROM AUTHOR]

Objective: To perform a comparative analysis of health care expenses and outcomes in response to the question: What is the cost-effectiveness of intralesional and perilesional recombinant human epidermal growth factor (rhEGF) compared with hydrocolloid therapy in patients diagnosed with chronic venous insufficiency without infection in Colombia?, Methods: A Markov model was used to determine cost effectiveness over a 5-year period, considering the perspective of the health system in Colombia. The study included patients aged >18 years diagnosed with chronic venous insufficiency and used clinical studies to calculate the probabilities of epithelialization, infection, recurrence, and mortality., Results: RhEGF is more expensive per unit than hydrocolloids, but it is proven to be effective at healing ulcers in 8 to 12 weeks, even in complex cases. Hydrocolloids, in contrast, typically require 29.5 weeks on average, and ≤46 weeks for complex cases. Despite the cost, rhEGF is more cost effective because it achieves results comparable with hydrocolloid therapy at a lower cost per additional quality-adjusted life-year., Conclusions: Based on cost-effectiveness analysis, rhEGF is a superior alternative to hydrocolloids for treating venous ulcers in Colombia. Not only is it more affordable, but it also enhances patients' quality of life and streamlines the health care system's resource use., Competing Interests: Disclosures O.M.-M. is a consultant for Praxis Pharmaceutical., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Diabetic foot ulcers commonly precede diabetic foot osteomyelitis (DFO) and once the latter occurs, surgical management is often performed. The presence of osteomyelitis is an independent risk factor for the development of re‐ulceration. We investigated the relationship between causative organisms in osteomyelitis and 1‐year diabetic foot outcomes (re‐ulceration, amputation, and death) following surgical management in an observational cohort of 223 patients. Univariate and multivariate analyses were performed for available demographic, clinical, and laboratory data. In addition, random forest plots were used to identify microbiologic predictors of 1‐year outcomes. Patients with osteomyelitis managed surgically were younger and exhibited more painful peripheral neuropathy than outpatients with diabetes alone (both P <.0001). Osteomyelitis proximal margin cultures were diverse, at times polymicrobial, and included multidrug‐resistant organisms in 13.9% of the cohort. In patients who underwent surgery, 44.5% experienced a re‐ulceration on the same foot within 12 months of surgery. The presence of multidrug‐resistant organisms on proximal bone culture was found to be a significant predictor of diabetic foot ulcer recurrence in univariate modelling (P <.001) and importance rankings. This is the first study to use prediction modelling to identify a relationship between multidrug‐resistant organisms and diabetic foot ulcer recurrence following DFO. [ABSTRACT FROM AUTHOR]

Abstract Background Home monitoring of foot temperatures in high-risk diabetes patients proves to be a promising approach for early recognition and treatment of pre-signs of ulceration, and thereby ulcer prevention. Despite previous studies demonstrating its efficacy, it is currently not widely applied in (Dutch) health care. Methods In a multicenter, outcome-assessor-blinded, randomized controlled trial, 304 patients with diabetes mellitus types I or II, loss of protective sensation based on peripheral neuropathy, and a history of foot ulceration in the preceding 4 years or a diagnosis of Charcot neuro-osteoarthropathy will be included. Enhanced therapy will consist of usual care and additional at-home daily measurement of foot temperatures at six to eight predefined locations on the foot. If a contralateral foot temperature difference of > 2.2 °C is found on two consecutive days, the participant is instructed to contact their podiatrist for further foot diagnosis or treatment, and to reduce ambulatory activity by 50% until temperatures are normalized. Enhanced therapy will be compared to usual care. The primary outcomes are the cost (savings) per patient without a foot ulcer (i.e., cost-effectiveness) and per quality-adjusted life year gained (i.e., cost-utility). The primary clinical outcome in the study is the proportion of patients with foot ulcer recurrence on the plantar foot, apical surfaces of the toes, the interdigital spaces or medial and lateral forefoot surfaces during 18-month follow-up. Discussion Confirmation of the efficacy of at-home foot temperature monitoring in ulcer prevention, together with assessing its usability, cost-effectiveness and cost-utility, could lead to implementation in Dutch health care, and in many settings across the world. Trial registration Netherlands Trial Registration: NTR5403. Registered on 8 September 2015.

Recent studies demonstrate favorable diabetic foot ulcer (DFU) healing outcomes with the implementation of a multidisciplinary team. We aimed to describe the incidence of and risk factors associated with ulcer recurrence after initial complete healing among a cohort of patients with DFU treated in a multidisciplinary setting. All patients presenting to our multidisciplinary diabetic limb preservation service from 6/2012-04/2018 were enrolled in a prospective database. The incidence of ulcer recurrence after complete wound healing was assessed per limb using the Kaplan-Meier method, and a stepwise multivariable Cox proportional hazards model was created to identify independent predictors of ulcer recurrence. A total of 244 patients with 304 affected limbs were included. Ulcer recurrence rates at one and 3 y after healing were 30.6 ± 3.0% and 64.4 ± 5.2%, respectively. Recurrent ulcers were smaller (4.4 ± 1.1 cm2 versus 8.2 ± 1.2 cm2; P = 0.04) and had a lower Wound, Ischemia, and foot Infection stage (stage 4: 7.7% versus 22.4%; P < 0.001) than initial ulcers, and wound healing time was significantly reduced (95.0 ± 9.8 versus 131.8 ± 7.0 d; P = 0.004). Independent predictors of ulcer recurrence included abnormal proprioception (HR, 1.57 [95% CI 1.02-4.43]) and younger age (HR 1.02 per year [95% CI 1.01-1.04]). In this prospective cohort of patients with DFU, time to diagnosis and healing was significantly lower for recurrent ulcers, and downstaging was common. These data suggest that engaging patients with DFU in a multidisciplinary care model with frequent follow-up and focused patient education may serve to decrease DFU morbidity. [ABSTRACT FROM AUTHOR]

Objective: To compare clinical and operative results between laparoscopic primary repair (LPR) alone and LPR with highly selective vagotomy (LPR-HSV) in patients with duodenal ulcer perforation., Methods: Clinical data from patients who underwent either LPR or LPR-HSV by resecting both sides of the neurovascular bundle using an ultrasonic or bipolar electrosurgical device for duodenal ulcer perforations, between 2010 and 2020, were retrospectively collected. Between-group differences in continuous and categorical variables were statistically analysed., Results: Data from 184 patients (mean age, 49.6 years), who underwent either LPR ( n  = 132) or LPR-HSV ( n  = 52) were included. The mean operation time was significantly longer in the LPR-HSV group (116.5 ± 39.8 min) than in the LPR group (91.2 ± 33.3 min). Hospital stay was significantly shorter in the LPR-HSV group (8.6 ± 2.6 days) versus the LPR group (11.3 ± 7.1 days). The mean postoperative day of starting soft fluid diet was also significantly shorter in the LPR-HSV group (4.5 ± 1.4 days) than in the LPR group (5.6 ± 4 days). No between-group difference in morbidity rate was observed. The learning curve of the HSV procedure showed a stable procedure time after 10 operations., Conclusions: LPR with HSV may be a safe and feasible procedure for selective cases who are at high risk for ulcer recurrence., Competing Interests: Declaration of conflicting interestsThe authors declare that there are no conflicts of interest.

Objectives The aim of this study was to assess the mid-term ulcer recurrence rate in patients with healed or active venous ulcers treated with endovenous laser ablation (EVLA) for incompetent superficial axial veins and to search for possible risk factors for non-healing and recurrence. Methods Consecutive patients treated with EVLA because of a healed or active venous ulcer between 2006 and 2013 were identified in the medical records and quality registry and invited to follow-up, including clinical history, study examination, Duplex ultrasound scanning, ankle brachial pressure, photoplethysmography, venous clinical severity score (VCSS), and health related quality of life (HRQoL) measured with EQ5D. Of 228 patients, 170 (195 legs) fulfilled the inclusion criteria. Twenty patients were interviewed by phone, 27 were unreachable and 11 were excluded. Univariate and multivariate regression analyses were performed to identify possible risk factors for recurrence. Results The mean follow-up time was 41 months (range 14–89 months). The average age was 66.6 years (range 36–87 years). All 86 legs operated on for an active ulcer had this ulcer healed sometime between the operation and the study examination, but thereafter it recurred in 14 patients (16%). In 109 legs operated on for a healed ulcer, the ulcer recurred in 17 legs (16%). Complications such as permanent sensory loss were seen in 16 legs (8%) and deep venous thrombosis in two legs (1%). Thirty legs (15%) were re-treated for superficial venous incompetence (SVI). Reduced ankle mobility was a risk factor for recurrence in both univariate and multivariate analysis ( p = .048). Conclusions These midterm results demonstrate that endovenous laser ablation of SVI in patients with healed or active venous ulcers achieves good healing and low ulcer recurrence rates, with a low rate of complications and an acceptable re-intervention rate. [ABSTRACT FROM AUTHOR]

The aim of our study was to identify risk factors for the recurrence of diabetic foot ulcers (DFUs) in a selected population of patients in secondary prevention treated, according to International Guidelines, with an integrated foot care protocol by a referral diabetic foot clinic. A retrospective study was performed with the inclusion of selected outpatients with diabetes at higher risk for ulceration with a history of previous ulcer and/or amputation followed in our diabetic foot clinic between January 2015 and December 2021. According to the presence or absence of recurrence, patients were divided into 2 groups: ulcer recurrence and without ulcer recurrence. One hundred twenty-seven (127) patients were included, 47 patients (37%) developed an ulcer recurrence while 80 patients (63%) did not. The mean age was 71.7 years; 65% were male; 97% were affected by type 2 diabetes with a mean duration of 21.1 years, the mean HbA1c was 63 + 21 mmol/mol. Both groups of patients had foot deformities, such as claw and hammertoes; hallux valgus, and prominent metatarsal heads (MTHs). The presence of deformity was significantly associated with ulceration. The group with ulcer recurrence showed a higher rate of prominence MTHs in comparison to a group without ulcer recurrence. The MTHs resulted as the only independent predictor for recurrence. This study shows that the presence of the prominent MTH is a significant risk factor for ulcer recurrence in a selected population of diabetic foot patients treated in the best way with integrated foot care.

Objective: National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported., Methods: The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis., Results: After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms., Conclusions: A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing., (Crown Copyright © 2022. Published by Elsevier Inc. All rights reserved.)

Metatarsal head resection is a common and standardized treatment used as part of the surgical routine for metatarsal head osteomyelitis. The aim of this study was to define the influence of the amount of the metatarsal resection on the development of reulceration or ulcer recurrence in patients who suffered from plantar foot ulcer and underwent metatarsal surgery. We conducted a prospective study in 35 patients who underwent metatarsal head resection surgery to treat diabetic foot osteomyelitis with no prior history of foot surgeries, and these patients were included in a prospective follow-up over the course of at least 6 months in order to record reulceration or ulcer recurrences. Anteroposterior plain X-rays were taken before and after surgery. We also measured the portion of the metatarsal head that was removed and classified the patients according the resection rate of metatarsal (RRM) in first and second quartiles. We found statistical differences between the median RRM in patients who had an ulcer recurrence and patients without recurrences (21.48 ± 3.10% vs 28.12 ± 10.8%; P = .016). Seventeen (56.7%) patients were classified in the first quartile of RRM, which had an association with ulcer recurrence (P = .032; odds ratio = 1.41; 95% confidence interval = 1.04-1.92). RRM of less than 25% is associated with the development of a recurrence after surgery in the midterm follow-up, and therefore, planning before surgery is undertaken should be considered to avoid postsurgical complications. [ABSTRACT FROM AUTHOR]

Objectives Determine the cost-effectiveness of three topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to standard care in the management of venous leg ulcers (VLUs). Methods A three-state Markov model derived from the medical literature was developed to estimate the comparative cost-effectiveness of three CTPs in relation to VLU standard care. CTPs evaluated in the study included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE). The three Markov states included unhealed, healed, and death. A 1-year time horizon was used to determine the number of ulcer-free weeks and the expected costs of therapies. The payer perspective was taken in the analysis and only the direct costs of care were considered. Sensitivity analyses were performed to gauge model parameter uncertainty. Results The expected costs for standard care, ECM, HSE, and LSE VLU therapy were $6,132, $6,732, $10,638, and $11,237, while the expected outcomes were 24, 31, 29, and 27 ulcer-free weeks, respectively. ECM was economically dominant among the three CTPs. In the base case of ECM versus standard care, the incremental cost-effectiveness ratio for ECM therapy was $86 per ulcer-free week. Sensitivity analysis did not alter ECM dominance. Clinic visits and home health utilization exhibited the greatest influence on cost. Conclusions ECM is the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. These findings suggest that VLU standard care therapy with ECM can yield potential cost savings and produce better outcomes than do other CTPs. [ABSTRACT FROM AUTHOR]

Aims: To assesses the relationship between the wear and tear of therapeutic footwear (TF) and the risk of recurrence in diabetes remission patients.Methods: Remission patients (N = 115) participated in this 5-year prospective study in a specialized Diabetic Foot Unit between October 2016 and January 2022. Patients' TF was assessed in a three-month interval from Day 0 until ulcer recurrence was found. Primary outcome measure was based on the recurrent event in the forefoot.Results: A total of 82 patients (71.3%) renewed their TF, and 33 patients (28.7%) did not renew their TF during the follow-up period. Patients who failed to renew their TF group experienced more recurrent events (22 vs 14, p <.001, CI [0.04-0.259]) and minor amputations (11 vs 8, p =.002, CI [0.07-0.6]). Both groups showed different recurrence-free survival median times of 205.5 [Interquartile range (IQR) - 188-222] weeks and 89.9 [IQR - 53-126] weeks. Patients who did not renew their TF increased their risk of suffering from a recurrent event in the Cox regression model (p <.001, CI [0.03-0.38], Hazzard Ratio 0.147).Conclusions: Patients who renewed their TF because of wear and tear experienced lower recurrences and minor amputations. [ABSTRACT FROM AUTHOR]

Background In the present study we: (i) evaluated the incidence of heart failure ( HF) in patients with diabetic foot ulcer ( DFU); and (ii) investigated the relationship between the clinical characteristics in these patients and prognosis. Methods The clinical characteristics of 330 consecutive Chinese patients (137 men, 193 women) hospitalized for DFU were collected and assessed to determine the effects of HF on DFU. All patients were followed for 3 months and rates of healing, the development of new ulcers, amputations, and mortality were calculated at the end of the follow-up period. Results Heart failure was present in 64.3% of patients with DFU, with the prevalence of HF increasing with Wagner grade from Wagner 1 through to Wagner 5 (42.4%, 59.1%, 64.7%, 73.3%, and 87.0%, respectively), higher than the 33.6% prevalence in diabetic patients without DFU ( Wagner 0). The presence of HF conferred a greater increased relative risk of a worse prognosis. The 3-month healing rates of DFU in patients with and without HF were 60.3% and 75.7%, respectively. Recurrence (13.2% vs 7.5%) and amputations (28.6% vs 20.0%) were more frequent in patients with than without HF ( P < 0.05). All-cause mortality was recorded for 14 of 126 patients with HF compared with three of 70 patients without HF (11.1% vs 4.3%, respectively; P < 0.05). Conclusions The prevalence of HF is high in Chinese inpatients with DFU, with the presence of HF indicating a worse prognosis for these patients. [ABSTRACT FROM AUTHOR]

Objective: An active venous leg ulcer (VLU) caused by lower extremity venous insufficiency is challenging to treat and will often recur after initially healing. In the present study, we compared the symptomatic outcomes and need for reoperation after iliac vein stenting (IVS) in patients with an active VLU (VLU+) and those without an active VLU (VLU-)., Methods: A single-institution database of patients with chronic venous outflow obstruction who underwent IVS from August 2011 to June 2021 was analyzed. Symptoms were quantified using the venous clinical severity score. The patients were divided into two cohorts: those with (VLU+) and without (VLU-) VLUs., Results: A total of 872 patients (71 VLU+ and 801 VLU-) were identified. Many of the demographics and comorbidities differed between the two cohorts, and these variables were included in the multivariable analysis. On univariate analysis, the VLU+ cohort was more likely to need a major reoperation (odds ratio, 1.94; 95% confidence interval, 1.01-3.52; P = .036). However, on multivariable analysis, the difference was not statistically significant (odds ratio, 1.17; 95% confidence interval, 0.55-2.40; P = .667). Additionally, the VLU+ cohort required a significantly greater mean total of reoperations (1.4 vs 1.0; P = .006) than the VLU- cohort. Comparatively, for patients who underwent at least one reoperation, the difference in the mean total number of reoperations was even greater for the VLU+ cohort (2.6 vs 1.8; P = .001). The results from the Kaplan-Meier log-rank test revealed no differences in the reintervention-free survival time (P = .980). Both cohorts experienced a durable mean reduction in the venous clinical severity score. The ulcer healing rates for the VLU+ cohort at 6, 12, 24, and 36 months were 38%, 47%, 52%, and 59%, respectively. The ulcer recurrence rates for the VLU+ cohort were 4%, 10%, 19%, and 30% at 6, 12, 24, and 36 months, respectively, with a median time to recurrence of 1.2 years., Conclusions: Patients with active VLUs who underwent a first reintervention after initial IVS, on average, required an additional reintervention., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The ESCHAR trial showed that superficial venous surgery and compression in chronic venous ulceration achieved a 24-week healing rate of 65% and 12-month recurrence rate of 12%. Foam sclerotherapy treatment is an alternative to surgery. The aim of this study is to assess the effect of foam sclerotherapy on ulcer healing and recurrence in chronic venous leg ulcers. Methods: Chronic venous leg ulcers (CEAP [clinical, aetiological, anatomical and pathological elements] 5 and CEAP 6) with superficial venous reflux were treated between March 2006 and June 2011 with ultrasound-guided foam sclerotherapy and compression. Venous duplex was performed on all legs before and after treatment. Twenty-four-week ulcer healing and one- and four-year ulcer recurrence rates were calculated using Kaplan-Meier survival analysis. Results: Two hundred legs (186 patients) with chronic venous ulcers (CEAP 5: n = 163 and CEAP 6: n = 37) were treated with foam sclerotherapy. Complete occlusion was achieved in 185/200 (92.5%) limbs, short segment occlusion in 14/200 (7%) limbs and one leg segment failed to occlude. One patient suffered an asymptomatic non-occlusive deep vein thrombosis (DVT) diagnosed on duplex scan at one week and one presented with an occlusive DVT three weeks following a normal scan at one week. One patient developed an asymptomatic occlusive DVT at two weeks following a non-occlusive DVT diagnosed on initial one-week scan. Eighteen patients were lost to follow-up (3 moved away and 15 died of unrelated causes). The 24-week healing rate was 71.1% and one- and four-year recurrence rates were 4.7% and 28.1%, respectively. Conclusion: Foam sclerotherapy is effective in abolition of superficial venous reflux and may contribute to similar ulcer healing and long-term recurrence rates to superficial venous surgery. Foam sclerotherapy is an attractive alternative to surgery in this group of patients. [ABSTRACT FROM AUTHOR]

We aimed to investigate adherence to at-home monitoring of foot temperature and its association with patient-, disease- and behavior-related factors, in people with diabetes at high risk of ulceration. We analyzed 151 participants in the enhanced therapy arm of the DIATEMP trial (all at high diabetes-related foot ulcer risk) who aimed to perform and log foot temperatures daily for 18 months or until ulceration. Adherence was the proportion of measurement days covered (PDC), with being adherent defined as PDC≥70%. If a hotspot was recorded, adherence to subsequently reducing ambulatory activity was assessed. Multivariate logistic regression analysis was performed to investigate associations with adherence. We found ninety-four participants (62.3%) adherent to measuring foot temperatures. This was higher in months 1-3 versus months 4-18: 118 (78.1%) versus 78 (57.4%; P  < .001). Of 83 participants with a hotspot, 24 (28.9%) reduced ambulatory activity. Increasing age ( P  = .021, OR = 1.045) and better self-care ( P  = .007, OR = 1.513) were positively associated with adherence to measuring foot temperature. In conclusion, in people at high diabetes-related foot ulcer risk, adherence to measuring foot temperature was high in the first months after study commencing, but dropped over time. Adherence to reducing ambulatory activity when a hotspot was found was low over the entire study period.