Clinical Trials Resource Center

New Medical Therapies™

Venous Leg Ulcers

August 5, 2013

Pergamum reported results of a phase I/II study of LL-37 in patients with chronic leg ulcers. In the double-blind, multi-center study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37 (0.5mg/ml, 1.6mg/ml and 3.2mg/ml). Top-line results show patients treated with LL-37 for one month experienced an improved healing rate compared to placebo for the two lower doses. The average healing rate in patients receiving 0.5mg/ml or 1.6mg/ml was three to six times higher than in the placebo group, and this difference was statistically significant (p<0.05). The drug was well-tolerated when it was applied to venous leg ulcers at the two lower doses (0.5mg/mL and 1.6mg/mL). However, an increased incidence of local reactions at the treated wounds was observed in the highest dose group (3.2mg/ml) and there was no improvement in wound healing in comparison with placebo.

August 29, 2011

Advanced BioHealing issued results from a phase III trial of Dermagraft, their bio-engineered skin substitute, for the treatment of venous leg ulcers. This randomized, controlled study enrolled over 500 subjects across international sites. The subjects received weekly applications of Dermagraft plus four-layer compression dressings or four-layer compression dressings alone. When combined with compression therapy, Dermagraft achieved a higher closure rate of venous leg ulcers than compression therapy alone. However, the data did not meet the primary endpoint of complete healing of the ulcer by the end of the 16-week treatment period. The company has decided not to pursue the venous leg ulcer indication.

August 8, 2011

Healthpoint Biotherapeutics released results from a phase IIb trial of HP802-247 for the treatment of venous leg ulcers. This US-based, randomized, double-blind, dose-finding study enrolled 228 adults with venous leg ulcers (between 2 cm2 and 12 cm2) for a minimum of six weeks and a maximum of 24 months. The subjects received two cell concentrations and two dosing frequencies of HP802-247 or placebo, both combined with standard care, for 12 weeks. HP802-247 achieved statistical significance, as compared with control plus standard care, in both the primary and secondary endpoints: average percent change from baseline in the target wound area over the 12-week double-blind treatment (p≡0.04), and time in days to complete wound closure from baseline (p≡0.02). HP802-247 was generally safe and well tolerated.

May 31, 2010

CoDa Therapeutics reported positive results from a phase II study evaluating Nexagon for venous leg ulcers. This three-arm trial, dubbed NOVEL, randomized 98 subjects to low or high dose Nexagon or placebo, in addition to compression bandaging (standard-of-care). After three applications over a four-week treatment period, high-dose Nexagon demonstrated a 69% reduction in the size of venous leg ulcers. In addition, complete healing of 31% of wounds seen in the high-dose treatment arm was five times higher than complete healing in the vehicle arm. No drug-related adverse events were observed in either of the low or high dose Nexagon arms.

April 6, 2009

RegeneRx issued positive results from a phase II trial of RGN-137, a topical gel formulation of thymosin beta 4 peptide, for the treatment of venous stasis ulcers. This randomized, double-blind, placebo-controlled, dose-escalation study enrolled 72 subjects in Italy and Poland. The subjects received three escalating concentrations of RGN-137 (0.01%, 0.03%, and 0.1%) or placebo, along with standard of care, applied topically, once daily for up to 84 consecutive days. The efficacy endpoints were the percent of subjects with complete wound healing and time to complete wound healing. In the mid-dose group, 33% of subjects had complete healing compared to 24% in the placebo group. Complete healing was observed in 16% of the low-dose group and 17% in the high-dose group. Of those patients in the mid-dose group with complete healing, RGN-137 decreased the median time to complete healing by approximately 40% compared to placebo. RGN-137 was safe and well tolerated at all three dose levels.

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