Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study.

OBJECTIVE: To determine the frequency of skin cancers associated with chronic leg ulcers (CLUs) presumably of vascular origin and failing to heal (ie, increased wound area or depth) despite 3 months or more of appropriate treatment. DESIGN: Prospective cross-sectional study. SETTING: Ambulatory or hospitalized patients from 17 dermatology departments. PATIENTS: Between January 1, 2006, and May 31, 2008, a total of 144 patients consulted for CLUs, attributed to venous and/or peripheral arterial disease(s), increasing in wound size, that is, larger area and/or depth, despite appropriate standard treatment for at least 3 months. MAIN OUTCOME MEASURES: At inclusion, at least two 6-mm punch biopsies, 1 at the wound edge and 1 in the wound bed, in the most clinically suspicious areas, were systematically performed. The primary end point was the skin cancer frequency diagnosed in at least 1 wound biopsy specimen obtained at inclusion. RESULTS: The 144 patients included had 154 CLUs. The overall skin cancer frequency in the CLUs was 10.4%: 9 squamous cell and 5 basal cell carcinomas, 1 melanoma, and 1 leiomyosarcoma; 56.3% had persisted for at least 3 years. Univariate analyses retained older age, abnormal excessive granulation tissue at wound edges, high clinical suspicion of cancer, and number of biopsies, but not wound area or duration, as being significantly associated with skin cancer in 1 or more biopsy specimens. CONCLUSIONS: The combined primary ulcerated cancer or malignant transformation frequency was sufficiently high in CLUs referred to tertiary care centers to consider systematic biopsy of a wound refractory to 3 months or more of appropriate treatment.

A randomized, controlled, double-blind prospective trial with a Lipido-Colloid Technology-Nano-OligoSaccharide Factor wound dressing in the local management of venous leg ulcers.

Venous leg ulcers (VLUs) are the most prevalent chronic wounds in western countries with a heavy socioeconomic impact. Compression therapy is the etiologic treatment of VLU but until now no wound dressing has been shown to be more effective than another. The aim of this study was to assess the efficacy of a new dressing in the management of VLU. Adult patients presenting a noninfected VLU and receiving effective compression therapy were enrolled in this randomized, controlled, double-blind trial. The VLUs were assessed every 2 weeks for 8 weeks. The primary study outcome was the relative Wound Area Reduction (WAR, in %), and the secondary objectives were absolute WAR, healing rate, and percentage of wounds with >40% surface area reduction. One hundred eighty-seven patients were randomly allocated to treatment groups. Median WAR was 58.3% in the Lipido-Colloid Technology-Nano-OligoSaccharide Factor (TLC-NOSF) dressing group (test group) and 31.6% in the TLC dressing group (control group) (difference: -26.7%; 95% confidence interval: -38.3 to -15.1%; p = 0.002). All other efficacy outcomes were also significant in favor of the TLC-NOSF dressing group. Clinical outcomes for patients treated with the new dressing are superior to those patients treated with the TLC dressing (without NOSF compound), suggesting a strong promotion of the VLU healing process.

Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial.

OBJECTIVE: To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers. DESIGN: Randomized, double-blind, parallel-assignment, controlled study. SETTING: Ambulatory or hospitalized patients from 17 dermatology departments. PATIENTS: Among 64 consecutive randomized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed. INTERVENTION: Becaplermin gel (human recombinant platelet-derived growth factor-BB, 0.1%, in hydrogel) or hydrogel dressing was applied, both in doses of 1 cm/cm(2), once daily for 8 weeks. Follow-up continued for 4 weeks beyond the final gel application. MAIN OUTCOME MEASURES: The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of patients with complete wound closure at week 12; changed ulcer area after treatment vs baseline; and changed ulcer-related pain and health-related quality of life during the study. RESULTS: Complete wound closure rates were comparable after 8 weeks for becaplermin (5 of 28 patients) and hydrogel (3 of 31 patients) (8 percentage-point difference; 95% confidence interval, -10% to 26%). No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12, changed ulcer area at week 8, or changed ulcer-related pain and quality of life during the study (P > .05 for all comparisons). CONCLUSIONS: Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation. Trial Registration clinicaltrials.gov Identifier: NCT00970697.

[Etiological diagnosis of leg ulcers]. / Diagnostic étiologique des ulcères de jambe.

Etiological diagnosis of leg ulcers must be the first step of treatment, even if we know that veinous disease is often present. We can build a clinical decisional diagram, which helps us to understand and not forget the other causes of chronic wounds and choose some basic examination, like ultrasound and histological findings. This diagnosis helps to choose the right treatment in order to cure even the oldest venous ulcers. Educational programs should be improved to prevent recurrence.

Impact of protein deficiency on venous ulcer healing.

OBJECTIVE: The prevalence of protein deficiency and its impact on wound healing is not known for leg ulcers. The aim of this study was to determine the prevalence of protein deficiency in outpatients presenting with leg ulcers and the parameter's prognostic value for wound outcome. DESIGN OF STUDY: Prospective controlled observational study. SETTING: Ambulatory patients referred for chronic wounds to four university hospitals. METHODS: Consecutive out-patients with a leg ulcer present for at least 2 months, related to venous insufficiency, associated or not with moderate peripheral arterial disease (ankle-brachial pressure index > 0.7), were included in a prospective study. Wound evaluation (area and occurrence of complications) was performed at baseline and at 12 weeks of follow-up. Biologic nutrition assessment (serum albumin, transthyretin, c-reactive protein) was performed at baseline. The control group consisted of consecutive patients free of leg ulceration and attending the dermatology outpatient clinic for remissive skin cancer or miscellaneous skin disorders. RESULTS: Forty one patients and 43 controls were included. Serum albumin level was under 35 g/L (normal values: 36-44 g/L) in 27% of the patients and 2% of the controls (P < .001). At 12 weeks, 34% of the patients had an increase in wound area. Wound infections occurred in 12% (n = 5) of the patients. Protein deficiency was independently associated with an increase in wound area at 12 weeks (P = .034) and the presence of an inflammatory syndrome was associated with the occurrence of wound complications (wound infection or hospitalization) during follow-up (P < .001). CONCLUSION: The prevalence of protein deficiency in out-patients with leg ulcers is high and significantly associated with a poor healing prognosis.

Dressings for acute and chronic wounds: a systematic review.

OBJECTIVE: To critically review the literature on the efficacy of modern dressings in healing chronic and acute wounds by secondary intention. DATA SOURCES: Search of 3 databases (MEDLINE, EMBASE, and the Cochrane Controlled Clinical Trials Register) from January 1990 to June 2006, completed by manual research, for articles in English and in French. STUDY SELECTION: The end points for selecting studies were the rate of complete healing, time to complete healing, rate of change in wound area, and general performance criteria (eg, pain, ease of use, avoidance of wound trauma on dressing removal, ability to absorb and contain exudates). Studies were selected by a single reviewer. Overall, 99 studies met the selection criteria (89 randomized controlled trials [RCTs], 3 meta-analyses [1 of which came from 1 of the selected systematic reviews], 7 systematic reviews, and 1 cost-effectiveness study). DATA EXTRACTION: The RCTs, meta-analyses, and cost-effectiveness studies were critically appraised by 2 reviewers to assess the clinical evidence level according to a modification of Sackett's 1989 criteria. Ninety-three articles were finally graded. DATA SYNTHESIS: We found no level A studies, 14 level B studies (11 RCTs and 3 meta-analyses), and 79 level C studies. Hydrocolloid dressings proved superior to saline gauze or paraffin gauze dressings for the complete healing of chronic wounds, and alginates were better than other modern dressings for debriding necrotic wounds. Hydrofiber and foam dressings, when compared with other traditional dressings or a silver-coated dressing, respectively, reduced time to healing of acute wounds. CONCLUSIONS: Our systematic review provided only weak levels of evidence on the clinical efficacy of modern dressings compared with saline or paraffin gauze in terms of healing, with the exception of hydrocolloids. There was no evidence that any of the modern dressings was better than another, or better than saline or paraffin gauze, in terms of general performance criteria. More wound care research providing level A evidence is needed.