PROMOTION AND ACCELERATION OF DIABETIC ULCER HEALING BY ARGININE GLYCINE ASPARTIC-ACID (RGD) PEPTIDE MATRIX

OBJECTIVE - To determine the effectiveness and safety of arginine-glyc ine-aspartic acid (RGD) peptide matrix in the treatment of diabetic fo ot ulcers. RESEARCH DESIGN AND METHODS - This randomized placebo-contr olled investigator- and patient-blinded prospective multicenter invest igation was conducted at three institutional and three private U.S. cl inics providing ambulatory care. Sixty-five diabetic patients with chr onic full-thickness neurotrophic foot ulcers were enrolled. Six discon tinued the study because of adverse events. RGD peptide matrix (Argide ne Gel; formerly Telio-Derm Gel) was applied topically twice weekly fo r up to 10 weeks in patients who otherwise received standard care. Con trol 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 analysi s. RESULTS - The percentage of patients whose ulcers healed completely in the RGD peptide matrix group (35%; 14 of 40 patients) was over fou rfold greater (P = 0.02) than that in the placebo group (8%, 2 of 25 p atients). By the study end point (either day of healing or week 10), 3 0 of 40 (75%) RGD peptide matrix patients had achieved >50% ulcer clos ure compared with 12 of 25 (48%) placebo patients (P = 0.03). RGD pept ide matrix also significantly (P = 0.03) increased the rate of ulcer c losure over the 10 weeks of the study. CONCLUSIONS - RGD peptide matri x treatment promoted and accelerated the healing of chronic diabetic f oot ulcers to a significant degree.