OBJECTIVE - To determine the effectiveness and safety of arginine-glycine- aspartic acid (RGD) peptide matrix in the treatment of diabetic foot ulcers. RESEARCH DESIGN AND METHODS - This randomized placebo-controlled investigator- and patient-blinded prospective multicenter investigation was conducted at three institutional and three private U.S. clinics providing ambulatory care. Sixty-five diabetic patients with chronic full-thickness neurotrophic foot ulcers were enrolled. Six discontinued the study because of adverse events. RGD peptide matrix (Argidene Gel; formerly Telio-Derm Gel) was applied topically twice weekly for up to 10 weeks in patients who otherwise received standard care. Control group patients received topical saline as a placebo plus standard care. The primary method of assessment was the incidence and rate of ulcer closure. All patients enrolled were included in the data analysis. RESULTS - The percentage of patients whose ulcers healed completely in the RGD peptide matrix group (35%; 14 of 40 patients) was over fourfold greater (P = 0.02) than that in the placebo group (8%; 2 of 25 patients). By the study end point (either day of healing or week 10), 30 of 40 (75%) RGD peptide matrix patients had achieved >50% ulcer closure compared with 12 of 25 (48%) placebo patients (P = 0.03). RGD peptide matrix also significantly (P = 0.03) increased the rate of ulcer closure over the 10 weeks of the study. CONCLUSIONS - RGD peptide matrix treatment promoted and accelerated the healing of chronic diabetic foot ulcers to a significant degree.
|Number of pages||8|
|State||Published - Jan 20 1995|