ACCELERATED HEALING OF CHRONIC SICKLE-CELL LEG ULCERS TREATED WITH RGD PEPTIDE MATRIX

Leg ulcers are a chronic manifestation of sickle-cell disease (SCD) an d are often painful, disabling, and difficult to treat. RGD peptide ma trix treatment is a novel therapy designed to provide a topical synthe tic extracellular matrix that can act as a temporary substitute for th e damaged natural matrix at the ulcer site. In this randomized, placeb o-controlled, double-blind, prospective, multicenter investigation, SC D patients with full-thickness leg ulcers were treated with standard t herapy plus RGD peptide matrix or saline placebo once weekly for up to 10 weeks. Healing in patients with chronic ulcers (2 months or greate r in duration) was significantly accelerated (P = .0085) in RGD peptid e matrix recipients compared with the placebo group. In these chronic ulcer cases, the average percent ulcer closure (decrease in ulcer surf ace area) in the RGD peptide matrix group (54.4% +/- 8.9%) exceeded th at in the placebo group (19.0% +/- 24.3%) nearly threefold by study en dpoint. Furthermore, RGD peptide matrix was equally effective in promo ting healing of long persistent ulcers and ulcers of shorter duration. In contrast, standard therapy plus placebo was significantly less eff ective (P = .001) in promoting healing for ulcers of progressively gre ater duration. The results of this study provide preliminary evidence that RGD peptide matrix treatment may significantly accelerate healing of chronic sickle-cell leg ulcers. (C) 1994 by The American Society o f Hematology.