Therapy For Venous Ulcers Research Articles

Efficacy of Mobiderm® Bandage in Compression Therapy for Venous Ulcers: A Prospective Case Series.

Background: Venous leg ulcers severely affect patients' quality of life due to its high morbidity and recurrent nature. Currently, compression therapy is the first-line treatment for venous leg ulcers. Aim: This study sought to evaluate the efficacy of the Mobiderm® technology developed by Thuasne in a prospective case series of venous leg ulcers. Methods: Nine patients (N = 9) with venous leg ulcers were enrolled into this case series. Mobiderm® bandage was applied on to the affected limbs of the patients in the multi-component bandages system. The bandages were changed as frequent as the patients had their wound dressing for their standard treatment in a 12-week duration. Wound size and calf circumference were measured at week 0 and week 12. Paired sample t-test was used to compare the mean values of wound size and calf circumference pre- and post-treatment. Results: Reductions in wound size and calf circumference were observed in all nine patients (100%). Five patients were evaluable at week 12. The wound sizes significantly reduced by 27.2% to 53.2% (p = 0.02), and the calf circumferences significantly reduced by 3.2% to 26.0% (p = 0.02) after 12 weeks (N = 5). Safety was unremarkable, with no occurrence of treatment-emergent-related adverse event. Conclusion: Mobiderm® bandage was reported to be effective in promoting wound healing and reducing swelling, suggesting it to be integrated in the compression therapy for the management of venous leg ulcers.

Interventions for helping people adhere to compression treatments for venous leg ulceration.

Chronic venous ulcer healing is a complex clinical problem that requires intervention from skilled, costly, multidisciplinary wound-care teams. Compression therapy has been shown to help heal venous ulcers and to reduce recurrence. It is not known which interventions help people adhere to compression treatments. This review is an update of a previous Cochrane review. To assess the benefits and harms of interventions designed to help people adhere to venous leg ulcer compression therapy, to improve healing and prevent recurrence after healing. In June 2015, for this first update, we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched trial registries, and reference lists of relevant publications for published and ongoing trials. There were no language or publication date restrictions. We included randomised controlled trials (RCTs) of interventions that aim to help people with venous leg ulcers adhere to compression treatments compared with usual care, or no intervention, or another active intervention. Our main outcomes were ulcer healing, ulcer recurrence, quality of life, pain, adherence to compression therapy and number of people with adverse events. Two review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial, and assessed overall quality of evidence for the main outcomes in 'Summary of findings' tables. One randomised controlled trial was added to this update making a total of three. One ongoing study was also identified.One trial (67 participants) compared a community-based Leg Club® that provided mechanisms for peer-support, assistance with goal setting and social interaction with home-based care. There was no clear difference in healing rates at three months (12/28 people healed in Leg Club group versus 7/28 in home-based care group; risk ratio (RR) 1.71, 95% confidence interval (CI) 0.79 to 3.71); or six months (15/33 healed in Leg Club group versus 10/34 in home-based care group; RR 1.55, 95% CI 0.81 to 2.93); or in quality of life outcomes at six months (MD 0.85 points, 95% CI -0.13 to 1.83; 0 to 10 point scale). The Leg Club may lead to a small reduction in pain at six months, that may not be clinically significant (MD -12.75 points, 95% CI -24.79, -0.71; 0 to 100 point scale, 15 point reduction is usually considered the minimal clinically important difference) (low quality evidence downgraded for risk of selection bias and imprecision).Another trial (184 participants) compared a community-based, nurse-led self-management programme of six months' duration promoting physical activity (walking and leg exercises) and adherence to compression therapy via counselling and behaviour modification (Lively Legs®) with usual care in a wound clinic. At 18 months follow-up, there were no clear differences in healing rates (51/92 healed in Lively Legs group versus 41/92 in usual care group; RR 1.24 (95% CI 0.93 to 1.67)); rates of recurrence of venous leg ulcers (32/69 with recurrence in Lively Legs group versus 38/67 in usual care group; RR 0.82 (95% CI 0.59 to 1.14)); or adherence to compression therapy (42/92 people fully adherent in Lively Legs group versus 41/92 in usual care group; RR 1.02 (95% CI 0.74 to 1.41)). The evidence from this trial was also downgraded to low quality due to risk of selection bias and imprecision.A single study compared patient education delivered via video with education delivered by text (pamphlet). However, no outcomes relevant to this review were reported.We found no studies that investigated other interventions to promote adherence to compression therapy. It is unclear whether interventions designed to help people adhere to compression therapy improve venous ulcer healing and reduce recurrence. There is a lack of trials of interventions that promote adherence to compression therapy for venous ulcers.

Systematic review and meta-analysis of surgical interventions versus conservative therapy for venous ulcers

This goal of this study was to systematically review the literature to determine if surgical intervention (open or endovascular) is superior to compression alone with respect to ulcer healing, ulcer recurrence, and time to ulcer healing in patients with lower extremity venous ulcer disease. We conducted a comprehensive search of multiple databases for randomized controlled trials (RCTs) and comparative observational studies from 1990 to December 2013. The interventions of interest were any open or endovascular surgical interventions on the venous system in the lower extremity compared with compression alone. We included 11 studies (seven RCTs and four observational studies) with moderate to increased risk of bias. The meta-analysis of all studies demonstrated increased healing rate (pooled risk ratio [RR], 1.06; 95% confidence interval [CI], 1.00-1.13; I(2) = 10%) and lower risk of recurrence (RR, 0.54; 95% CI, 0.34-0.85; I(2) = 27%) with open surgical procedures compared with compression. However, the meta-analysis of only RCTs showed no difference, possibly due to imprecision. The meta-analysis of three RCTs showed no difference in time to ulcer healing, -0.41 (95% CI, -0.89 to 0.07). Two studies of endovascular surgical procedures compared with compression showed no significant difference in ulcer healing (RR, 1.65; 95% CI, 0.43-6.32). One study of open surgical venous ligation and stripping compared with endovenous laser also showed no significant difference in ulcer recurrence (RR, 0.83; 95% CI, 0.21-3.27). Open surgical interventions may improve lower extremity venous ulcer healing. The quality of this evidence is low because the analysis was dominated by the results of observational studies. The current evidence does not definitively support the superiority of endovascular surgical interventions compared with compression alone.

The Indication of Negative Pressure Wound Therapy for Venous Ulcers

The Indication of Negative Pressure Wound Therapy for Venous Ulcers

Sistema especialista para apoiar a decisão na terapia tópica de úlceras venosas

Although the treatment of venous ulcers requires a set of specific knowledge, non-specialist nurses are unaware of the appropriate therapy, which is a concern in the topical therapy for these skin lesions. This paper aims to present an expert system to support the nursing decision making process in the topical therapy of venous ulcers. It is a development research implemented in five stages: system modeling, knowledge acquisition, knowledge representation from production rules, and system implementation and evaluation. The production rules are presented as well as some cases to simulate the expert system behavior, demonstrating the viability of its usage in nurse's practice. The system may support the decision making about the topical therapy of venous ulcers. However, ulcer evaluation should be correctly made, so that the system provides appropriate suggestions, allowing better organization and planning assistance.

Spray-Applied Cell Therapy With Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg ulcers: A Phase 2, Multicentre, Double-Blind, Randomised, Placebo-Controlled Trial

Conclusion: Venous ulcers can be healed with a spray formulation of allogeneic neonatal keratinocytes and fibroblasts without the need for tissue engineering. Summary: Venous insufficiency results from venous valve dysfunction or venous obstruction, or both, of the superficial or deep veins. Subsequent venous hypertension results in edema, tissue inflammation, and microcirculatory destruction. The end result can be a venous ulcer that can be notoriously difficult to heal, with many not responding to standard compression therapy. Surgery can result in reduced recurrence of venous ulceration, but no interventions on veins themselves have been shown to speed healing of chronic venous ulcers (Barwell JR, et al, Lancet 2004;363:1854-9). Nonsurgical therapies for venous ulceration have used tissue constructs of allogeneic adult keratinocytes. Such tissue constructs are fragile and have required incorporation of one or more dermis-like substitutes for delivery of the keratinocytes to the wound. In a large randomized controlled trial, repeated application of a tissue construct demonstrated an improvement in venous ulcer healing compared with standard compression therapy (Falanga V, Arch Dermatol 1998;134;293-300). However, allogeneic cells do not engraft. It is therefore unclear if an elaborate tissue construct is actually needed. HP802-247 is composed of cryopreserved allogeneic growth-arrested fibroblasts and keratinocytes derived from neonatal foreskin (Goedkoop R, Dermatol 2010;220:114-20). Success of foreskin-derived allogeneic keratinocytes in a two-component fibrin glue suggest that these cells can deliver essential growth factors to a nonhealing wound without the need for an elaborate tissue construct. In this study, the authors delivered growth-arrested allogeneic neonatal keratinocytes and fibroblasts to nonhealing venous ulcers using a spray, without an elaborate tissue construct. Outpatients from 28 centers in the United States and Canada with up to three ulcers, venous reflux confirmed by duplex ultrasound imaging and sufficient arterial flow for healing were randomized in a phase 2, double-blind, placebo-controlled trial. The study required that one ulcer measure between 2 and 12 cm in area and had persisted for 6 to 104 weeks. Randomization was by computer-generated block method in a 1:1:1:1:1 ratio to 5.0 × 105 cells/mL every 7 days or every 14 days, or 0.5 × 105 cells/mL every 7 days or every 14 days, or to vehicle alone every 7 days. All experimental groups received four-layer compression bandages. Trial monitors, trial sponsors, investigators, center personal, and patients were all masked to treatment allocation. The primary end point was the mean percentage change in wound area at the end of 12 weeks. Analysis was by intention to treat. There were 45 patients assigned to 5.0 × 105 cells/mL every 7 days, 44 patients to 5.0 × 105 cells/ mL every 14 days, 43 patients to 0.5 × 105 cells/mL every 7 days, 46 patients to 0.5 × 105 cells/mL every 14 days, and 50 patients to vehicle alone. There were 205 patients who completed all required study visits. Primary outcome analysis demonstrated greater mean reduction in wound area associated with active treatment compared with vehicle (P = .0446), with the dose of 0.5 × 105 cells/mL every 14 days showing the largest improvement compared with vehicle (15.98%, 95% confidence interval, 5.56-26.41; P = .0028). Adverse events were the same in all groups, with new skin ulcers and cellulitis occurring in >5% of patients. Comment: This was a large well-conducted randomized trial suggesting benefit in healing of venous leg ulcers with a spray application of allogeneic cells. This study, combined with previous work, suggested that allogeneic cell therapy for venous leg ulcers is likely to be effective. A larger study of the optimum dose of HP802-247 compared with standard therapy for venous leg ulcers seems indicated.

The combined algorithm of venous ulcer therapy

This prospective study was undertaken to find a new combined algorithm to help patients suffering from long-term chronic non-healing venous ulcers. A total number of 20 patients suffering from chronic venous ulcers and important co-morbidities such as diabetes mellitus or cardiac failure and not responding to other therapeutic modalities were treated at our surgical department with a combination of compressive sclerotherapy, and maggot debridement therapy (MDT) using larvae of green blowfly Lucilia sericata. Using the combined therapy we have achieved a significant clinical effect in 19 patients (95 %). In 1 patient, this effect was only impermanent while 5 patients (25 %) were completely cured. Eleven patients (55 %) benefited despite incomplete healing of the ulcer. With three of our patients we have lost contact. Even though the number of patients in our study is not large, we have achieved remarkable results with the combined algorithm of venous ulcer therapy. We start the healing process with compressive sclerotherapy and when this kind of therapy does not bring about the expected effect, we continue with Maggot debridement therapy. This combination of therapeutic modalities appears to be very effective and efficient (Fig. 2, Ref. 16).

Estudio coste-beneficio del trasplante de membrana amniótica para úlceras venosas de extremidades inferiores refractarias a tratamiento convencional

Background Standard compression therapy for venous ulcers of the legs does not promote healing. Although autografting accelerates tissue repair, it is difficult to use in patients with concomitant diseases or when multiple grafts are required. The amniotic membrane has been used as a covering material and promotes epithelialization, making it a good potential treatment option when autografts are not indicated. Objectives To analyze the literature on the safety and efficacy of amniotic membrane grafting and compare the cost of currently available grafts (autografts, amniotic membrane grafts, and biocompatible skin substitutes) to promote tissue repair in venous ulcers. Material and methods A systematic review of the literature on the use of amniotic membrane grafts for the treatment of venous ulcers was performed up to 2010. A cost-minimization analysis of direct healthcare costs was then performed (at 3 and 6 months). A sensitivity analysis was performed to confirm the stability of the results. Results Only 1 study addressing safety and efficacy was identified. The cost-minimization analysis showed that autografts are always the least-expensive option (€ 1053 compared with € 1825 for amniotic membrane grafts and € 5767 for biocompatible skin grafts). At 6 months, however, amniotic membrane grafts would have cost € 6765 less than the use of biocompatible skin substitutes. Conclusions Despite having excellent therapeutic potential for the re-epithelialization of venous ulcers that do not respond to conventional treatment, amniotic membrane transplant remains an experimental therapy. Autograft is the most efficient treatment but amniotic membrane graft is less expensive than the use of biocompatible skin substitutes.

Cost-Benefit Analysis of Amniotic Membrane Transplantation for Venous Ulcers of the Legs That Are Refractory to Conventional Treatment

Background Standard compression therapy for venous ulcers of the legs does not promote healing. Although autografting accelerates tissue repair, it is difficult to use in patients with concomitant diseases or when multiple grafts are required. The amniotic membrane has been used as a covering material and promotes epithelialization, making it a good potential treatment option when autografts are not indicated. Objectives To analyze the literature on the safety and efficacy of amniotic membrane grafting and compare the cost of currently available grafts (autografts, amniotic membrane grafts, and biocompatible skin substitutes) to promote tissue repair in venous ulcers. Material and methods A systematic review of the literature on the use of amniotic membrane grafts for the treatment of venous ulcers was performed up to 2010. A cost-minimization analysis of direct healthcare costs was then performed (at 3 and 6 months). A sensitivity analysis was performed to confirm the stability of the results. Results Only 1 study addressing safety and efficacy was identified. The cost-minimization analysis showed that autografts are always the least-expensive option (€ 1053 compared with € 1825 for amniotic membrane grafts and € 5767 for biocompatible skin grafts). At 6 months, however, amniotic membrane grafts would have cost € 6765 less than the use of biocompatible skin substitutes. Conclusions Despite having excellent therapeutic potential for the re-epithelialization of venous ulcers that do not respond to conventional treatment, amniotic membrane transplant remains an experimental therapy. Autograft is the most efficient treatment but amniotic membrane graft is less expensive than the use of biocompatible skin substitutes.

Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

BackgroundThe incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.Methods/DesignThe trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm2 or >10 cm2. Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.DiscussionThe aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.Trial RegistrationACTRN12608000599370

Treatment of venous leg ulcers with an ointment containing yarrow (Achillea millefolium) extract / Primena preparata sa ekstraktom hajdučke trave (Achillea millefolium) u lečenju venskih ulkusa potkolenice

Abstract Traditional medicine credits yarrow (Achillea millefolium) with the ability to accelerate wound healing. The purpose of this research was to determine the effects of yarrow on the epithelization of the lower leg venous ulcers. The study included 39 patients with venous leg ulcers. They were divided into two groups: the first (experimental) group of patients were treated with an ointment containing 7.5% of yarrow extract. In the second (control) group, saline solution dressings were applied to ulcers, within the period of three weeks. In the experimental group, at the beginning of the therapy, the total surface of all the ulcers was 44736 mm2. After three weeks, the total surface of all the ulcers was 27000 mm2 (a decrease of 39.64%). In the control group, at the beginning of the therapy, the total surface of all the ulcers was 46116 mm2. At the end of the study (21 days) the total surface of all the ulcers was 39153 mm2 (a decrease of 15.1%). Herbal preparations are suitable for application in the therapy of venous ulcers, but their efficiency in wound healing is still to be investigated.

Guidelines for diagnosis and therapy of venous ulcers (version 8 2008)

SummaryFour years after the publication of the latest guidelines on diagnosis and therapy of venous ulcer the German Society of Phlebology defines a completely revised and expanded version after the review of the literature published in the meantime. Particular emphasis was laid on international standards, new chapters are related to socio-economic aspects, the physical perception of the patients and the implementation of the guidelines in clinical practice.

Guidelines for diagnosis and therapy of venous ulcers (version 8 2008)

SummaryFour years after the publication of the latest guidelines on diagnosis and therapy of venous ulcer the German Society of Phlebology defines a completely revised and expanded version after the review of the literature published in the meantime. Particular emphasis was laid on international standards, new chapters are related to socio-economic aspects, the physical perception of the patients and the implementation of the guidelines in clinical practice.

Venous ulcers

Chronic venous ulceration is a common and important medical problem, which causes significant morbidity. Venous ulcers are expensive to treat, have substantial economic effects in terms of days of work lost, and adversely impact patient's quality of life. History and clinical findings are helpful in making the diagnosis of venous ulceration, but additional diagnostic testing is helpful in confirming the diagnosis and excluding arterial disease. The objectives of venous ulcer management include healing of the ulcer, prevention of recurrence, and improvement of edema. Compression is the cornerstone of venous ulcer therapy. Adjunctive modalities such as biologic skin substitutes, dressings, debridement, surgical intervention, and drugs may also facilitate the healing process.

Compression Therapy for Venous Ulcers

Compression Therapy for Venous Ulcers

Randomized clinical trial of three-layer paste and four-layer bandages for venous leg ulcers: Meyer FJ, McGuinness CL, Lagattolla NRF, et al. Br J Surg 2003;90:934-40

ConclusionThree-layer compressive bandages are slightly more effective than four-layer compressive bandages for healing venous leg ulcers. SummaryOne hundred thirty-three patients with venous ulcers treated in a single clinic were stratified according to ulcer size and then randomized to receive three-layer or four-layer bandages. Ulcers were stratified by calculating the maximum length and breadth of the ulcer and multiplying these values. Ulcers were grouped into small (>0.25–<2.5 cm2), medium (2.5-25 cm2 ), and large (25-100 cm2 ) groups. Ulcers smaller than 0.25 cm2 or larger than 100 cm2 were excluded. Patients were excluded if they had diabetes, connective tissue disorders, rheumatoid arthritis, or human immunodeficiency virus, or were positive for sickle cell disease.Three-layer bandages consisted of a hypoallergenic paste, followed by a compression bandage, followed by Tubigrip. Four-layer bandages were comprised of orthopedic wool, a crepe bandage followed by a compressive bandage, and finally a Coban bandage. Patients were followed up for 1 year. Time to complete healing, defined as “restoration of entirely unbroken skin integrity without any purulent discharge after removal of all scabs,” was the primary end point.Complete ulcer healing occurred in 80% of patients treated with three-layer bandages and 65% of patients treated with the four-layer bandaging technique (P = .031). The median time to complete healing was 12 and 16 weeks, respectively (P = .04). The difference in healing did not become apparent until after 20 weeks of treatment. Large venous ulcers were less likely to heal. The adverse effect of ulcer size on healing was apparent in both the three-layer and four-layer bandage groups. Previous venous thrombosis or popliteal reflux did not affect ulcer healing. CommentBoth four-layer and three-layer bandaging techniques are effective in management of venous leg ulcers, with three-layer bandages apparently slightly more efficacious. Neither technique is suitable for all patients. In some patients allergy will develop to the paste component of the three-layer bandage, and other patients find the four-layer bandage bulky and uncomfortable. Not all forms of compression therapy are suitable for all patients. Physician and patient willingness to explore alternative management techniques is crucial to success of conservative therapy of venous ulcers.

Regionalanästhesie als Alternative zur Allgemein- und zur Tumeszenzlokalanästhesie bei der operativen Deckung von ausgedehnten Ulcera cruris

erative Therapy of Large Venous Stasis Ulcers. A large proportion of patients with venous stasis ulcers are elderly and/or have significant co-morbidity. In such patients general anaesthesia can only be performed accepting an increased risk. On the other hand, subcutaneous infusion anaesthesia may not be satisfactory if ulcers are large and if there is marked dermatoliposclerosis. We consider regional anaesthesia an alternative. Suitable for the operative therapy of venous ulcers is in particular a combination of a block of the N. femoralis and the N. ischiadicus. Using this technique a large nearly circumferential venous stasis ulcer could be completely healed with meshed skin grafts in a 82 year old woman.

The cost effectiveness of larval therapy in venous ulcers

The treatment of necrotic ulcers involves considerable nursing time and expense. The current standard treatment involves repeated application of hydrogels. Larval debridement therapy (LDT) has been shown anecdotally to clear ulcers of necrotic slough but has never been compared directly with `modern' therapies. The aim of this study has been to compare LDT with hydrogel dressings in the treatment of necrotic venous ulcers. 12 patients with sloughy venous ulcers were randomised to receive either LDT or the control therapy — a hydrogel. Effective debridement occurred with a maximum of one larval application in 616 patients. 216 in the hydrogel group still required dressings at one month. The median cost of treatment of the larval group was £78.64 compared with £136.23 for the control treatment group (p<0.05). The study confirms both the clinical efficacy and cost effectiveness of larval therapy in the debridement of sloughy venous ulcers.

Compression therapy of venous ulcers.

Compression therapy of venous ulcers.

Compression-induced pulsatile blood flow changes in human legs.

Initial and sustained (7-h) impacts of foot-to-knee compression bandaging on leg arterial pulsatile blood flow were assessed by nuclear magnetic resonance flowmetry in eight healthy supine subjects. A widely used bandaging method (zinc impregnated gauze + Coban) and a slight variant (Coban only) were applied one week apart to one leg. Blood flow was measured on each day of bandage application before and after bandaging and after 7 h of normal activity. Initial mean sub-bandage pressures (lateral gaiter) were between 28.4 and 28.9 mmHg but were significantly reduced after 7 h to 16.3-19.4 mmHg. Overall below-knee pulsatile blood perfusion was initially significantly increased by both methods mainly due to increased proximal blood flow. Bandaging was also associated with a decrease in blood perfusion of the nonbandaged control leg mainly due to a decrease in distal blood flow. Neither of these effects were sustained after 7 h. The fact that neither sub-bandage pressure nor blood flow was sustained may indicate a causal linkage, a concept consistent with the finding of a linear relationship between afternoon blood flow and sub-bandage pressure reductions. The implications of the present findings for venous ulcer therapy are speculative and based on the concept that arterial pulsatile flow augmentation is a positive feature. If so, more frequent bandage changes to provide transient flow stimulation or use of bandages to better maintain sub-bandage pressure to sustain flow increases may be useful.