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Giovanni Mosti,1 Stefano Gasperini2 1Barbantini Clinic, Lucca, Italy; 2Medical Advisor, Pisa, Italy Abstract: Chronic skin lesions are an important medical health problem. Chronic skin lesions are associated with high costs for the National Health Service and reduced quality of life for the patient. The availability of means to reduce the healing time of skin ulcers is a medical and public health priority. Within this context, for patients suffering from skin ulcers, great attention has been given to the use of particular frequencies of the light spectrum that have shown beneficial effects on both ulcer cleansing and healing stimulation. This article reports the observations made on three patients suffering from ulcers of the lower limbs who were treated with Photobiomodulation therapy using Blue Light in addition to the standard treatment at a private clinic. The results were encouraging and have prompted us to participate in a protocol of a multicenter randomized study on a significant number of patients. Keywords: photobiomodulation, blue light emitting diodes, wound healing, chronic leg skin lesion

Abstract BackgroundComplications from hyaluronic acid (HA) fillers are increasingly frequent, given the very high number of treatments performed every day worldwide. They are routinely treated with high doses of hyaluronidase, which can cause significant local and general unwanted effects. ObjectivesThe aim of our work is to demonstrate that when the origin of the complication is precisely identified and treated under ultrasound guidance, a few hyaluronidase units are enough to treat it effectively. MethodsFive young female patients came to our observation for vascular lesions from injection of HA fillers performed in the immediately preceding days, in 4 cases, and a few weeks earlier in the fifth case. All lesions were accurately identified by ultrasound and treated with hyaluronidase. ResultsThe 4 promptly treated patients fully recovered with a hyaluronidase dose of 87 ± 44 IU (range, 30-150 IU). The fifth patient, treated later, markedly improved regarding clinical picture and symptoms. No early or late side effects have been reported from this hyaluronidase dosage. ConclusionsOur data confirm that if the lesion at the origin of the skin damage is precisely localized with ultrasound examination and treated under ultrasound guidance, a few units of hyaluronidase, injected directly into the HA accumulation, effectively resolve the skin damage. At the doses we used, which were much lower than those usually recommended, hyaluronidase proved to be not only effective but also free of any side effects. Level of Evidence: 5

Objective: Although compression therapy (CT) is considered a crucial conservative treatment in chronic venous disease, strong evidence is missing for many clinical indications. This literature review aims to point out what strong evidence we have for CT and all the clinical scenarios where strong evidence still needs to be included., Methods: The research was conducted on MEDLINE with PubMed, Scopus and Web of Science. The time range was set between January 1980 and October 2022. Only articles in English were included., Results: The main problem with CT is the low scientific quality of many studies on compression. Consequently, we have robust data on the effectiveness of CT only for advanced venous insufficiency (C3-C6), deep vein thrombosis and lymphedema. We have data on the efficacy of compression for venous symptoms control and in sports recovery, but the low quality of studies cannot result in a strong recommendation. For compression in postvenous procedures, superficial venous thrombosis, thromboprophylaxis, post-thrombotic syndrome prevention and treatment, and sports performance, we have either no data or very debated data not allowing any recommendation., Conclusions: We need high-level scientific studies to assess if CT can be effective or definitely ineffective in the clinical indications where we still have a paucity of or contrasting data., Competing Interests: Disclosures None., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Venous leg ulcers (VLUs) are the most severe complication caused by the progression of chronic venous insufficiency. They account for approximately 70-90% of all chronic leg ulcers (CLUs). A total of 1% of the Western population will suffer at some time in their lives from a VLU. Furthermore, most CLUs are VLUs, defined as chronic leg wounds that show no tendency to heal after three months of appropriate treatment or are still not fully healed at 12 months. The essential feature of VLUs is their recurrence. VLUs also significantly impact quality of life and could cause social isolation and depression. They also have a significant avoidable economic burden. It is estimated that the treatment of venous ulceration accounts for around 3% of the total expenditure on healthcare. A VLU-free world is a highly desirable aim but could be challenging to achieve with the current knowledge of the pathophysiology and diagnostic and therapeutical protocols. To decrease the incidence of VLUs, the long-term goal must be to identify high-risk patients at an early stage of chronic venous disease and initiate appropriate preventive measures. This review discusses the epidemiology, socioeconomic burden, pathophysiology, diagnosis, modes of conservative and invasive treatment, and prevention of VLUs.

Objective: The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking., Methods: This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume., Results: All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001)., Conclusion: The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5-0.8) occurs as in mixed leg ulcers (MLU)., Materials and Methods: in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure <40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU., Results: Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP ( p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP ( p = -0.19)., Conclusions: when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

Background: The literature supports the use of graduated compression stockings (GCS) for leg edema. Nevertheless, there is a paucity of data on the GCS effect on limb edema related to sitting, standing, and walking. Data of different limb shapes and their impact on GCS-exerted pressure are lacking. This investigation provides evidence-based information on the effect of GCS on edema reduction and the impact of limb circumference gradients on GCS pressure., Methods: Thirty healthy individuals (15 men and 15 women; mean age, 32 ± 5 years) were included. All the participants underwent lower limb volume (Kuhnke formula) measurement, before and after sitting for 30 minutes, wearing below-ankle noncompressive socks. The same assessment was repeated 7 days later, in the same participants, but with wearing of below-knee 16 to 20 mm Hg GCS. At 7-day intervals, 1 week with below-ankle noncompressive socks and 1 week with below-knee 16 to 20 mm Hg GCS, all the participants repeated the same protocol including standing and walking. Ten participants underwent bioimpedance assessment (Biody Xpert II; eBIODY, La Ciotat, France) before and after sitting, standing, and walking. In the same group, B and B1 interface pressure values were measured., Results: Data collection was completed in all 60 limbs. Sitting or walking without GCS led to no significant volume changes, whereas volume was decreased by the use of GCS (-4.8% [P < .00001] and -4.4% [P < .00001], respectively). Standing up without GCS led to an increase in volume (2.7%; P < .0001), whereas limb volume was decreased (4.6%; P < .0001) by use of GCS. Bioimpedance showed extracellular water reduction only while walking with GCS (from 40.55% ± 1.66% to 40.45% ± 1.71%; P < .017). Mean interface pressure was 19 ± 5 mm Hg (B) and 16 ± 5 mm Hg (B1). The interface pressure variation from B to B1 was not homogeneous among participants (mean percentage variation of -13% ± 25%, ranging from -54% to 16%). A negative linear trend between pressure variation and circumference percentage increase was found; the subanalysis excluding the two outliers showed a strong negative linear correlation (Pearson coefficient r = -0.96)., Conclusions: GCS led to a significant limb volume reduction irrespective of limb position and muscle pump function. However, extracellular fluid is mobilized only during muscle contraction while walking with GCS. Interestingly, different lower limb circumference variations influence the interface pressure gradient, indicating the importance of proper fitting of both B and B1 during prescription. These data provide a foundation to future investigations dealing with GCS effect on fluid mobilization and with limb geometry impact on compression performance., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)

Background: Strain gauge plethysmography (SGP) is employed to evaluate venous drainage of the lower leg., Methods: In this study, SGP was used to evaluate the effects of the hydrostatic pressure (HP) of water on venous volume (VV), expelled volume, and ejection fraction (EF) in 22 healthy legs before and during immersion in water., Results: HP reduced VV by 100% and even more during underwater (UW) exercise, making calculation of the UW EF possible., Discussion: UW SGP is feasible and indicates that HP improves venous haemodynamics. This study suggests that including UW leg exercise in the rehabilitation protocols of patients with chronic venous disease may be useful., Keywords: Strain gauge plethysmography, Underwater compression, Underwater ejection fraction, Underwater venous volume., (© 2020 The Authors.)

Objective: Despite the modern appeal of wearing compressive garments during physical activities, the literature is lacking in quality data and controversial in the investigations dealing with the pathophysiologic mechanism by which graduated compression stockings (GCS) affect the calf pump activation in healthy individuals. The aim of the investigation was to provide insight into the clinical effects of GCS use during a standardized walking exercise., Methods: Twenty physically active healthy volunteers (mean age, 34 ± 5 years; body mass index, 22 ± 2 kg/m 2 ) underwent lower limb ultrasound scanning to exclude vascular impairment. All individuals performed continuous aerobic exercise, walking for 30 minutes on a treadmill, under cardiac monitoring, at 70% of individual estimated maximal heart rate according to the Tanaka equation. The study population performed the standardized walk without GCS (baseline) and at 1 week performed the same standardized walk wearing knee-length 20 to 30 mm Hg GCS (compression). All individuals underwent a lower limb volume assessment by truncated cone formula before and after the walk and a perceived exertion assessment by means of the validated Borg scale at the end of the exercise protocol., Results: All individuals had normal venous and arterial ultrasound examination findings. No significant postural defects were reported. Both legs were assessed in all 20 individuals for a total of 40 cases with and 40 cases without GCS. In the baseline group, the median (interquartile range) lower limb volume changed from 2496 (770) mL before exercise to 2512 (805) mL (P = .2597) after exercise. The compression group reported a significant lower limb volume change from 2466 (670) mL before exercise to 2276 (567) mL (P = .0001) after exercise. Mean perceived exertion was 13 (11) and 11 (1) in the baseline and compression groups, respectively (P = .0001). The interface pressure exerted by the GCS was 24 (2) mm Hg. No complaints in terms of discomfort were reported after use of GCS., Conclusions: In healthy individuals, GCS (24 [2] mm Hg) use during a continuous standardized walk of 30 minutes is associated with a significant decrease in lower limb volume and a decrease in perceived exertion. The mechanism by which GCS impart their effect during physical activity may involve improved muscle pump function and reductions in inflammatory pathways. Further study will need to validate the mechanisms of the function of GCS used during physical exercise., (Copyright © 2019 Society for Vascular Surgery. All rights reserved.)

Background: For the currently used compression therapy, the applied compression pressure is usually inadequate to exert an effective impact on the veins in different body positions. The aim was to assess the venous ejection fraction achieved by a new compression device which automatically adjusts the interface pressure to body position in an acute experimental setting., Methods: A new portable, battery driven compression device providing pressure adjusted to allow for body position, and connected to a less or very stiff calf cuff wrap was tested. In patients with superficial venous incompetence, the ejection fraction (EF) of the calf pump was measured by strain gauge plethysmography. Applied in a random sequence, values achieved without compression, with the two cuffs, and with compression stockings exerting 23-32 mmHg, were compared. The applied compression pressures were simultaneously recorded in the supine and standing positions, and during walking. Comfort was assessed by a visual analogue scale (VAS) with 0 corresponding to very low comfort and 10 to very comfortable., Results: In 16 patients with CEAP clinical stage C3-C6, EF without compression was 37%, increasing to 46.9% with stockings, to 64.8% (p < .001) by less stiff and to 75.5% (p < .001) by stiffer wraps. The median interface pressure (supine/standing) was 31/56 mmHg for the less stiff device, 32/68 mmHg for the stiffer device, and 23/26 mmHg for the stockings. The static stiffness index and the walking pressure amplitudes were significantly higher than those generated by the stocking, and the highest values were found with the stiffer wrap material. The device comfort was high both in the supine and standing positions (VAS 8 ± 2)., Conclusions: The tested devices were comfortable at rest and haemodynamically effective during walking by automatically adjusting compression pressures to body position. They are significantly more effective than elastic stockings in improving EF. The system is able to overcome the problems of fast pressure loss by continuously re-adjusting the compression pressure., (Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Guideline 1.1: Compression after thermal ablation or stripping of the saphenous veins. When possible, we suggest compression (elastic stockings or wraps) should be used after surgical or thermal procedures to eliminate varicose veins. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 1.2: Dose of compression after thermal ablation or stripping of the varicose veins. If compression dressings are to be used postprocedurally in patients undergoing ablation or surgical procedures on the saphenous veins, those providing pressures >20 mm Hg together with eccentric pads placed directly over the vein ablated or operated on provide the greatest reduction in postoperative pain.[GRADE - 2; LEVEL OF EVIDENCE - B] Guideline 2.1: Duration of compression therapy after thermal ablation or stripping of the saphenous veins. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after treatment. [BEST PRACTICE] Guideline 3.1: Compression therapy after sclerotherapy. We suggest compression therapy immediately after treatment of superficial veins with sclerotherapy to improve outcomes of sclerotherapy. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 3.2: Duration of compression therapy after sclerotherapy. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after sclerotherapy. [BEST PRACTICE] Guideline 4.1: Compression after superficial vein treatment in patients with a venous leg ulcer. In a patient with a venous leg ulcer, we recommend compression therapy over no compression therapy to increase venous leg ulcer healing rate and to decrease the risk of ulcer recurrence. [GRADE - 1; LEVEL OF EVIDENCE - B] Guideline 4.2: Compression after superficial vein treatment in patients with a mixed arterial and venous leg ulcer. In a patient with a venous leg ulcer and underlying arterial disease, we suggest limiting the use of compression to patients with ankle-brachial index exceeding 0.5 or if absolute ankle pressure is >60 mm Hg. [GRADE - 2; LEVEL OF EVIDENCE - C]., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Bandage application does not exert consistent compression pressure, leading to extremely variable compression when applied to patients. A new elastic bandage can exert a predefined pressure independently of healthcare providers and the size of the wrapped limb. The bandage system includes a series of non-stretchable patches that when applied to the bandage make it stiff. The aim of this work was to assess, in an experimental setting, the venous ejection fraction (EF) from the lower leg and the tolerability of this new bandage in a group of patients affected by superficial venous incompetence., Methods: EF was measured using strain gauge plethysmography under baseline conditions and the bandage was applied with a supine pressure of 20 and 30 mmHg, with and without the stiff patches, in 25 patients with severe venous reflux in the great saphenous vein. The interface pressure of the bandages was measured simultaneously in the medial gaiter area., Results: All patients showed EF values that were significantly reduced compared with normal individuals. Elastic bandages with an average pressure of 20 and 30 mmHg in the supine position achieved a slight improvement in EF, and, after applying non-stretchable patches on the same bandage with similar resting pressure, EF was restored to its normal range (p < .001). Improvement in EF correlates with the pressure differences between standing and lying pressure and between muscle systole and diastole during exercise., Conclusion: This study confirms that inelastic is much more effective than elastic compression for improving impaired venous haemodynamics. The test material can be applied with a predetermined pressure, which considerably enhances the consistency of application, and it is easily transformed into an inelastic system just by applying stiff patches without any stretch and without significantly increasing the comfortable supine pressure., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: This was a prospective observational study to assess the short- to mid-term efficacy and safety of catheter foam sclerotherapy (CFS) of the great saphenous vein (GSV), including peri-saphenous tumescence infiltration (PST) and intra-saphenous saline irrigation (ISI), in combination with phlebectomy of the varicose tributaries., Methods: Eighty-eight limbs in 82 patients (19 male, 63 female, mean age 55.7 years) affected by varices related to GSV incompetence were submitted to CFS of the refluxing GSV segment after PST and ISI, combined with phlebectomy of the varicose tributaries. Sodium tetradecylsulfate (STS) 3% + CO 2 /O 2 sclerosant foam (SF) (median 7 mL) was injected in the GSV trunk (median caliber 7.1 mm) by means of a 4F catheter. Clinical and colour duplex ultrasound (CDU) investigation was performed pre-operatively, and 40 days, 6, 12, and 36 months post-operatively. A visual analogue scale (VAS) was used to assess procedure related symptoms and venous symptoms before and 40 days after the treatment., Results: Clinical recurrence (visible varices) at 40 days, 6 and 12 months was 0%, whereas at 36 months it was 4.7%; VAS pre-operative score of heaviness, pain, and cramps/paraesthesiae decreased from 6 (IQR 6-8) to 1 (IQR 0-3), from 3 (IQR 0-7) to 0 (IQR 0-1), and from 3 (IQR 0-7) to 0 (IQR 0-1) respectively at 40 days. The CDU based occlusion rate at 40 days, 6, 12, and 36 months was 100% (88/88), 100% (88/88), 94.3% (83/88), and 89.4% (76/85) respectively. Six of the nine patent saphenous veins (average diameter 1.4 mm) had anterograde flow (overall 96.5% reflux free GSVs). One superficial venous thrombosis was recorded without any further relevant complication., Conclusions: GSV treatment by means of CFS and adjuvant PST + ISI, combined with phlebectomy of varicose tributaries, proved to be safe and effective in terms of clinical and duplex based outcomes at short/mid-term follow-up., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Venous leg ulcer (VLU) is a huge healthcare problem with poorly understood pathophysiology. Transforming growth factor-β (TGF-β) and endoglin (Eng), are inflammatory and wound healing mediators. Eng, co-receptor for TGF-β type-II receptors, may be cleaved forming soluble Eng (sEng), antagonizing TGF-β signaling, a crucial process in vascular pathologies. We evaluated the accumulation in wound fluid (WF) of TGF-β isoforms and sEng in healing stages, showing the effects of sulodexide treatments, a glycosaminoglycan with clinical efficacy in VLU healing. Patients with inflammatory (Infl) and granulating (Gran) VLU were recruited. WFs and THP-1 monocytes exposed to Infl and Gran WF (treated/untreated with sulodexide) were analyzed for TGF-β isoforms and sEng by multiplex immunoassay. In both Infl and Gran WF, TGF-β1 and β2 were similar; TGF-β3 was significantly increased in Infl compared to Gran WFs ( p = 0.033). sEng was significantly elevated in Gran compared to Infl WFs ( p = 0.002). In THP-1 monocytes there was a significant increase in sEng after co-treatment of WF and sulodexide. The increase in TGF-β3 found in Infl WF highlights its negative effect on wound healing, while the increased levels of sEng in Gran WF affects the leukocyte adhesion/transmigration through the endothelium, reducing the inflammatory response and favoring the wound healing. Glycosaminoglycan sulodexide potentiates the effects of sEng release from monocyte, representing an important therapeutic option for wound healing., Competing Interests: The authors declare no conflict of interest.

An observational study of 2 years was promoted by the Italian Association for Cutaneous Ulcers (AIUC) in order to monitor the epidemiology of leg ulcers, the trend of healing and the more frequent therapeutic approaches in lower limb ulcers. Fifty-nine sites in 14 different Italian regions involved in the study, with 1333 enrolled patients (1163 patients fully evaluated and followed up for 9 months). A prevalence of females (62%) was observed with a mean age of 70 years and a high rate of hypertension (62%), diabetes (38%) and obesity (29%). Venous ulcer was most frequent (55%), followed by mixed (25%) and diabetic (8·3%) ulcers. Basically, all patients received a local therapy (LT) (compression and advanced local therapies), while 63% of patients have an associated systemic pharmaceutical treatment. Ulcer healing rates progressively increased throughout the study and despite the type of observational study does not allow conclusions on the treatment, it was observed that the patients receiving additional systemic drugs were associated with a more rapid acceleration of healing rates of ulcers compared to LT alone (3 months: 39·7% versus 29·2%; 6 months: 62·0% versus 47·0%; 9 months: 74·7% versus 63·8%). In particular, the Studio Ulcere Vascolari (SUV) study showed that a combination treatment with sulodexide and compression therapy allows for a greater increase in the healing rates in venous ulcers., (© 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)