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PubMed1992

A prospective, randomized trial of Unna's boot versus Duoderm CGF hydroactive dressing plus compression in the management of venous leg ulcers.

Leg ulcers caused by chronic venous insufficiency plague an estimated 500,000 Americans, but there have been few improvements in conservative treatment in this century, and Unna's boot continues to be a mainstay of therapy. A recent report suggests that Duoderm CGF dressing provides greater patient comfort and enhanced compliance, but Duoderm alone (without compression) resulted in slower healing compared with Unna's boot. We enrolled 30 patients (30 ulcers) in a clinical trial to compare Duoderm CGF plus compression (Coban wrap) to Unna's boot. No significant difference was observed between the two groups with respect to age, sex, initial ulcer area, ulcer duration, or extent of venous insufficiency by duplex scan. Eight of 16 ulcers (50%) in the Duoderm group healed completely versus 6 of 14 ulcers (43%) in the Unna's boot group (p = 0.18). Healing rates (square centimeters per week) correlated significantly with initial ulcer area and initial ulcer perimeter for both groups but best correlated with initial ulcer perimeter (r = 0.88 with Duoderm, p less than 0.0001; r = 0.80 with Unna's boot, p less than 0.002). After adjusting for differences in initial ulcer perimeter, healing rates were significantly faster for patients on Duoderm than patients on Unna's boot during the first 4 weeks of therapy (0.384 +/- 0.059 cm2/wk/cm perimeter for Duoderm versus 0.135 +/- 0.043 cm2/wk/cm perimeter for Unna's boot; p = 0.002). At 12 weeks patients on Duoderm again appeared to heal faster than those on Unna's boot, although the result did not reach statistical significance (0.049 +/- 0.007 cm2/wk/cm perimeter for Duoderm versus 0.020 +/- 0.017 for Unna's boot, p = 0.11).(ABSTRACT TRUNCATED AT 250 WORDS)

Analysis of Variance↗
PubMed2005

[Management of venous leg ulcers].

Leg ulcers are a major health and economic problem especially in elderly. More than 70% are associated with venous disease. Compressive therapy is the most effective treatment but bandages are often poorly tolerated and well trained nurses are required to apply them effectively. In recent years, the VAC system (vacuum assisted closure) has profoundly changed the wound healing approach. The objective is now to regenerate the tissues and not to replace them with skin grafts which give uncertain results. The other important challenge is to prevent recurrences. New pharmacologic treatments acting on microcirculation and hemostasis would probably appear in the near future opening new therapeutic perspectives.

Humans↗
PubMed2000

Surgical correction of isolated superficial venous reflux reduces long-term recurrence rate in chronic venous leg ulcers.

OBJECTIVES: surgical correction of isolated superficial venous reflux in ulcerated legs may reduce short term recurrence rates but the longer term benefits are unknown. DESIGN: prospective non-randomised cohort study. METHODS: consecutive patients with chronic leg ulcers were prospectively assessed at a one-stop clinic over a 4-year period from July 1995 to July 1999. All patients with ankle brachial pressure indices (ABPI)50.85 were initially treated with weekly four-layer bandaging. Venous duplex studies in all ulcerated legs assessed venous reflux pattern with surgery being offered to all those with isolated superficial reflux, of whom 56% accepted. Patients were advised to wear class two elastic compression stockings after healing. RESULTS: 766 legs in 669 patients were assessed. Six hundred and thirty-three legs had an ABPI50.85, 236 (39%) demonstrating isolated superficial venous reflux. Surgery was performed on 131 of these legs. Twelve and 24 week healing rates were 50% and 72% for operated legs and 62% and 74% for non-operated legs (p=0.67; Kaplan-Meier life table analysis). Recurrence rates at 1, 2 and 3 years were 14%, 20% and 26% for operated legs and 28%, 30% and 44% for non-operated legs (p=0.03; Kaplan-Meier life table analysis). CONCLUSION: surgical correction of superficial venous reflux in legs with chronic leg ulceration may reduce ulcer recurrence rate at 1, 2 and 3 years.

Adult↗
PubMed2000

Oral pentoxifylline for treatment of venous leg ulcers.

BACKGROUND: Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers do not respond to compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers but to date there has been no systematic review. OBJECTIVES: To assess the effects of pentoxifylline ('Trental 400') for treating venous leg ulcers, when compared with placebo, or in comparison with other therapies, in the presence or absence of compression therapy. SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases and Wounds Groups specialised registers (date of search August 1999), and reference lists of relevant articles. We hand searched relevant journals and conference proceedings, and contacted Hoechst (the manufacturer of the drug) and experts in the field. SELECTION CRITERIA: Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in patients with venous leg ulcers. DATA COLLECTION AND ANALYSIS: Details from eligible trials were extracted and summarised by one reviewer using a coding sheet. Data extraction was independently verified by one other reviewer. MAIN RESULTS: Nine trials involving 572 adults were included. The quality of trials was variable. Eight trials compared pentoxifylline with placebo; in five of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. By pooling eight trials that compared pentoxifylline with placebo (with or without compression) it was found pentoxifylline was more effective than placebo in terms of complete healing or significant improvement (relative risk for healing with pentoxifylline compared with placebo 1.41, 95% confidence interval 1.19 -1.66). Pentoxifylline and compression was more effective than placebo and compression (relative risk for healing with pentoxifylline 1.30, 95% confidence interval 1.10-1.54). Combination of similar trials using compression obtained a number needed to treat (NNT) of 7 (95%confidence interval 4-17). A comparison between pentoxifylline and defibrotide found no difference in healing rates. More adverse effects were reported in the pentoxifylline group, although this was not statistically significant (relative risk for adverse effects with pentoxifylline 1. 25, 95% confidence interval 0.87-1.80). Nearly half of the adverse effects were reported to be gastro-intestinal. REVIEWER'S CONCLUSIONS: Pentoxifylline appears to be an effective adjunct to compression bandaging for treating venous ulcers. There was no cost effectiveness data available and healthcare commissioners may therefore conclude that it not be considered a routine adjunct. Pentoxifylline in the absence of compression may be effective for treating venous ulcers in the absence of compression, although the evidence should be cautiously interpreted. The majority of adverse effects are likely to be tolerated by patients, and gastrointestinal disturbances (indigestion, diarrhoea and nausea) are the most frequent adverse effect.

Administration, Oral↗
PubMed1997

Trial of two bandaging systems for chronic venous leg ulcers.

A four-layer bandaging system developed at Charing Cross Hospital has been found to be effective in healing chronic venous ulcers but is not available on the Drug Tariff. An alternative system was devised from bandages available on the Drug Tariff and a community-based randomised controlled trial was undertaken to compare the two systems. Twenty-nine patients with a total of 35 ulcerated legs were recruited. Equal numbers of ulcerated legs healed using the two compression systems. Nineteen ulcerated legs did not heal, of which six were withdrawn from the trial-two in the trial system and four in the Charing Cross system. Of the 13 remaining ulcerated legs, for which treatment was completed, the mean reduction in ulcer area was 34% with the trial system and 39% with the Charing Cross system. The change in ulcer area was not statistically significant. However, a much larger trial is required in order to demonstrate definitively that the two bandaging systems are equivalent.

Bandages↗
PubMed2006

Advances in the management of leg ulcers--the potential role of growth factors.

Venous ulcers are a major health problem because of the increased costs of the treatment and the refractory nature of the ulcers. The treatment cost is estimated to be around 1 billion dollars per year in the United States (US), and the average cost for one patient over a lifetime exceeds dollars 400,000. There has been an increasing trend in the use of growth factors in their management. Genetic engineering has revolutionised the research of wound healing, as the majority of recombinant growth factors are now available for in vitro and in vivo studies. Online searches of Medline, Pub Medical and Embase were carried out using the terms venous ulcers, leg ulcers, growth factors and growth hormone. The literature regarding the potential role of growth factors in the management of leg ulcers is reviewed. The important clinical studies are critically analysed with a view to appreciate the emerging therapies and the further research possibilities in the management of venous leg ulcers. Clinical results with the use of growth factors in non-healing wounds are encouraging. However, small sample sizes and inconsistent end points in different clinical studies have been the main hurdle in reaching a definite conclusion. Further research is needed to provide the definite evidence. Future developments may include different delivery methods for the growth factors, use of different combinations of growth factors administered simultaneously or, sequentially, bioengineered skin grafts and chemical induction of angiogenesis with the use of gene transfer techniques.

Growth Substances↗
PubMed1999

Economic evaluation of the treatment of chronic wounds: hydroactive wound dressings in combination with enzymatic ointment versus gauze dressings in patients with pressure ulcer and venous leg ulcer in Germany.

OBJECTIVE: The treatment costs for pressure ulcers and venous leg ulcers were estimated based on the hospital administrator's perspective in Germany. DESIGN: A spreadsheet model using input data from various hospitals in Germany was developed. INTERVENTIONS: Five currently used treatment strategies were analysed: gauze, impregnated gauze, calcium alginate and hydroactive wound dressing with enzymatic ointment. PARTICIPANTS: All cases used for and in the analysis were treated in the inpatient setting (4 hospitals and 120 patients were included). MAIN OUTCOME MEASURES AND RESULTS: The outcome distributions were calculated using the Monte Carlo method. For the whole treatment process, the attributable costs for the hospital were calculated for different cases (severity) and all treatment strategies (1997 values). The costs for treatment with gauze were the highest, whereas the costs for treatment with hydroactive wound dressings and enzymatic ointment were the lowest. The relation between personnel and material costs for gauze is approximately 95 to 5% and for hydroactive wound dressings 67 to 33%, respectively. The cost savings per case were between 1196 deutschmark (DM) and DM9826 using hydroactive wound dressings instead of gauze dressings (depending on the severity of the pressure ulcer), and between DM135 and DM677 for venous leg ulcers. The results were robust and did not change in any performed sensitivity analysis (parameter: 'personnel costs per minute', 'time required for changing a wound dressing', 'total number of wound dressing changes'). CONCLUSIONS: Despite the higher material costs of the hydroactive wound dressings in combination with enzymatic wound cleaning compared with other wound dressings, they should be recommended for the treatment of pressure ulcers and venous leg ulcers. This therapy alternative brings about significant reductions in total costs for hospitals because of significant reductions in personnel costs and the duration of treatment.

Alginates↗
PubMed2002

Cost-effectiveness of wound management in France: pressure ulcers and venous leg ulcers.

OBJECTIVES: This study set out to define realistic protocols of care for the treatment of chronic venous leg ulcers and pressure ulcers in France and, by developing cost-effectiveness models, to compare the different protocols of care for the two ulcer groups, enabling a calculation of direct medical costs per ulcer healed in a typical French health insurance plan. METHOD: Clinical outcomes and some treatment patterns were obtained from published literature. Validations of different treatment patterns were developed using an expert consensus panel similar to the Delphi approach. Costs were calculated based on national averages and estimates from the UK and Germany. The models were used to measure costs per healed ulcer over a 12-week period. RESULTS: For both the pressure ulcer and venous leg ulcer models, three protocols of care were identified. For pressure ulcers and venous leg ulcers, the hydrocolloid DuoDERM (ConvaTec, also known as Granuflex in the UK and Varihesive in Germany) was most cost-effective in France. CONCLUSION: The combination of published data and expert consensus opinion is a valid technique, and in this case suggests that treating pressure ulcers and venous leg ulcers with hydrocolloid dressings is more cost-effective than treating them with saline gauze, in spite of the lower unit cost of the latter.

Biological Dressings↗
PubMed2000

Leg ulcers in peripheral arterial disease (arterial leg ulcers): impaired wound healing above the threshold of chronic critical limb ischemia.

BACKGROUND: Peripheral arterial disease is the only identifiable etiology in approximately 10% of leg ulcers. Clinical data on the management of these chronic wounds are scarce. OBJECTIVE: We attempted to outline the threshold of systolic ankle pressure and ankle-brachial-index (ABI) below which arterial leg ulcers can occur and to outline the indication for revascularization in arterial leg ulcers. METHODS: Diagnostic and outcome analysis was performed for 26 consecutive patients with arterial leg ulcers. We calculated sensitivities, specificities, and receiver operating characteristic (ROC) curves for the identification of arterial leg ulcers among all 223 consecutive leg ulcer patients within a 3-year period, as well as the ROC curve for patients who required revascularization. RESULTS: The systolic ankle pressure was 88 (18-130) mm Hg (median; 95% confidence interval) and the ABI was 0.60 (0.15-0.86), respectively. Eighteen patients (69%) were subjected to revascularization. By the end of the study, 24 patients (92%) healed completely, 1 improved (90% wound closure), and 1 patient had to undergo below-knee amputation for chronic osteomyelitis. During this study, the ankle pressure and ABI were poor in distinguishing those patients who required revascularization from those who healed without revascularization. CONCLUSION: Most arterial leg ulcers do not meet the criteria of chronic critical limb ischemia, but they do not heal under conservative measures, either. A majority of these patients benefit from revascularization and should, therefore, be referred for arterial duplex ultrasound investigation or angiography. In our study, an ankle pressure below 110 mm Hg identified all patients (100%) who were subjected to revascularization procedures. However, controlled clinical studies are required to find the systolic ankle pressure and ABI below which revascularization can be recommended to speed up the healing time.

Aged↗
PubMed2000

Topical agents or dressings for pain in venous leg ulcers.

BACKGROUND: Venous leg ulcers affect up to 1 per cent of people at some time in their life. These ulcers are often painful and some clinicians choose dressings to reduce the pain both during and between dressing changes. OBJECTIVES: To assess the effectiveness of dressings, local anaesthetics/analgesics for pain relief in venous leg ulceration. SEARCH STRATEGY: Cochrane Wounds Group Register and the Cochrane Collaboration Field in Complementary Medicine were searched. Cochrane Pain Palliative and Supportive Care Group and Cochrane Wounds Group strategy were combined and used. SELECTION CRITERIA: All randomised controlled trials which evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement. DATA COLLECTION AND ANALYSIS: Eligibility for inclusion was confirmed by two reviewers who independently assessed the all potential trials. Details of eligible studies were summarised using a data extraction sheet which was checked by the second reviewer. MAIN RESULTS: No trial evaluated interventions for persistent pain. Three trials compared a eutectic mixture of local anaesthetic (EMLA) versus placebo for pain at debridement. All 3 trials reported a significant difference in pain in favour of EMLA, however, one of the trials favoured placebo in terms of number of ulcers healed at the end of the trial and another trial noted an increased incidence of burning and itching with the use of EMLA. REVIEWER'S CONCLUSIONS: EMLA may provide pain relief for venous leg ulcer debridement however, the effect of the product on ulcer healing and the incidence of itching and burning is unclear. Research is required to address questions such as the benefits of leg ulcer debridement and the impact of EMLA on healing and the incidence of burning and itching. There were no trials addressing the treatment of persistent pain and further research is warranted.

Administration, Topical↗
PubMed1995

Leg ulcers: a practical approach to the leg ulcer patient.

Wound care has become a complicated science and specialty field of its own; however, all patients are initially seen by the primary care provider, and it is here that the greatest impact on wound healing and limb salvage can be made. Clinicians frequently treat chronic leg ulcers with a variety of products at various costs to the patients and third party payors based on experience not scientific literature, making the interpretation of outcomes difficult. With the problem of leg ulcers being so common, this paper sets out to review the basics of wound healing common to all wounds and to describe the current concepts of management of the three most common leg ulcers seen in a typical outpatient wound clinic setting: venous stasis ulcers, ischemic ulcers, and diabetic foot ulcers.

Humans↗
PubMed1996

Optimizing the hospital management of leg ulcers.

BACKGROUND: Leg ulcers are common and are often the cause of a long hospital admission. However, little information is available on the efficacy and efficiency of inpatient leg ulcer management. The inpatient management of leg ulceration was examined and areas for improvement were sought. METHODS: The management of patients admitted to a teaching hospital with a primary diagnosis of leg ulceration was examined, the costs estimated and areas for improvement identified. A retrospective analysis of 174 admissions to Heidelberg Repatriation Hospital between 1 January 1991 and 31 December 1992 was performed. RESULTS: Of 119 patients, 61 had ulcers due to arterial disease and 34 due to venous disease. Over 2 years, leg ulcers accounted for 5259 inpatient bed days, a mean of 44.2 days per patient. The estimated cost exceeded $2,750,000, averaging over $12,000 per admission. Thirty-three percent of patients had no recorded investigations into the cause of their ulcer and fewer than 50% had documented improvement at discharge. CONCLUSIONS: Leg ulcers are costly due to their extended treatment on an inpatient basis. Unfortunately, hospital admission does not guarantee optimal wound healing rates. A leg ulcer protocol is proposed to minimize inpatient stay and improve investigation and management in an outpatient or community setting.

Aged↗
PubMed2002

Hormone replacement therapy and prevention of pressure ulcers and venous leg ulcers.

Pressure ulcers and venous leg ulcers are common chronic wounds. Oestrogens in the form of hormone replacement therapy (HRT) might have an effect on wound healing, but this possibility has not been studied in detail. Using a case-cohort study including elderly patients in the UK General Practice Research Database, we showed that patients who received HRT were less likely to develop a venous leg ulcer (age-adjusted relative risk 0.65 [95% CI 0.61-0.69]) or a pressure ulcer (0.68 [0.62-0.76]) than those who did not use HRT. Therefore, we believe that HRT could be beneficial for the prevention of these wounds.

Adult↗
PubMed1987

Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study.

Six hundred patients with chronic leg ulcers were interviewed and examined for evidence of arterial impairment. There were 827 ulcerated legs. Pedal pulses could not be felt in 94 (11%). A Doppler resting pressure index of 0.9 or less was found in 176 legs (21%). Risk factors for arterial impairment included age, ulceration affecting the foot, and a history of claudication, ischaemic heart disease, or cerebrovascular disease. Roughly half the patients with arterial impairment also showed the clinical features of chronic venous insufficiency. Careful assessment for arterial disease is mandatory before patients with chronic leg ulcers are treated with elastic compression.

Age Factors↗
PubMed2006

Electromagnetic therapy for treating venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis, or varicose ulcers) comprise 80 to 85% of all leg ulcers. Electromagnetic therapy is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of electromagnetic therapy on the healing of venous leg ulcers. SEARCH STRATEGY: For this first review update, we searched the Cochrane Wounds Group Specialised Register (last searched October 2005); CENTRAL (The Cochrane Library 2005, Issue 4); MEDLINE (1966 to October 2005); EMBASE (1980 to October 2005); and CINAHL (1982 to October 2005). SELECTION CRITERIA: Randomised controlled trials comparing electromagnetic therapy with sham electromagnetic therapy or other treatments. DATA COLLECTION AND ANALYSIS: For the original review, details of eligible studies were extracted and summarised using a data extraction sheet. Attempts were made to obtain missing data by contacting authors. A second reviewer checked data extraction. Meta-analysis was applied to combine the results of trials where the interventions and outcome measures were adequately similar. For this first update, two reviewers independently scrutinized the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. In the case of disagreements, a final decision was made either after discussion between two reviewers or consultation with a third party (a member of the Cochrane Wounds Group). MAIN RESULTS: This update identified no new trials. A total of three eligible RCTs were identified by the original review. Two trials compared the use of electromagnetic therapy with sham therapy and one trial compared it with standard topical treatments. One trial found a difference in healing rates of borderline statistical significance between electromagnetic therapy and sham therapy, although the direction of treatment effect was consistently in favour of electromagnetic therapy, the difference was not statistically significant. AUTHORS' CONCLUSIONS: There is currently no reliable evidence of benefit of electromagnetic therapy in the healing of venous leg ulcers. Further research is needed.

Electric Stimulation Therapy↗
PubMed2003

Medical pathology in patients with leg ulcers: a study carried out in a leg ulcer clinic in a day hospital for the elderly.

This study was undertaken to see if the multiple pathology previously found in elderly patients with leg ulcers (other than the ulcer) differed in older and younger patients. A retrospective survey of the case notes of 42 consecutive patients (19 males, 23 females) admitted to a medically staffed leg ulcer clinic based in a geriatric day hospital was carried out. Twenty one patients were aged < or = 74 years (including seven aged < or = 59 years) and 21 aged > or = 75 years. Medical conditions known on referral and illnesses diagnosed during attendance were identified. The high incidence of disease in both age groups was identical, with 57% of patients with four or more diagnoses. No patient had no medical illness in addition to their ulcer. The commonest was cardiovascular disease followed by arthritis, obesity and endocrine disease. Nineteen per cent of all diagnoses were made at the clinic. Medical treatment, including drug reviews, in addition to compression bandaging and other local treatment, was found to be helpful for healing the ulcer. Medical input to leg ulcer clinics is therefore important.

Aged↗
PubMedDate not supplied

Adapting national and international leg ulcer practice guidelines for local use: the Ontario Leg Ulcer Community Care Protocol.

BACKGROUND: Because of growing resources devoted to individuals requiring community care for leg ulcers, the authority responsible for home care in Ottawa, Ontario, Canada, established and evaluated a demonstration leg ulcer service. In an effort to provide current and evidence-based care, existing leg ulcer clinical practice guidelines were identified and appraised for quality and suitability to the new service. PROCESS: The Practice Guideline Evaluation and Adaptation Cycle guided development of a local protocol for leg ulcer care, which included: (1) systematically searching for practice guidelines, (2) appraising the quality of identified guidelines using a validated guideline appraisal instrument, (3) conducting a content analysis of guideline recommendations, (4) selecting recommendations to include in the local protocol, and (5) obtaining practitioner and external expert feedback on the proposed protocol. Updating the protocol followed a similar process. RESULTS: Of 19 identified leg ulcer practice guidelines, 14 were not evaluated because they did not meet the criteria (ie, treatment-focused guidelines, written in English and developed after 1998). Of the 5 remaining guidelines, 3 were fairly well developed and made similar recommendations. The level of evidence supporting specific recommendations ranged from randomized clinical trial evidence to expert opinion. By comparing the methodologic quality and content of the guidelines, the Task Force reached consensus regarding recommendations appropriate for local application. Two additional guidelines were subsequently identified and incorporated into the local protocol during a scheduled update. CONCLUSIONS: Local adaptation of international and national guidelines is feasible following facilitation of the Practice Guidelines Evaluation and Adaptation Cycle.

Community Health Services↗