SODIUM CARBOXYMETHYLCELLULOSE AQUEOUS-BASED GEL VS. BECAPLERMIN GEL IN PATIENTS WITH NONHEALING LOWER-EXTREMITY DIABETIC ULCERS

The efficacy and safety of topically applied sodium carboxymethylcellu lose (NaCMC) aqueous-based gel in conjunction with good wound care pra ctices were compared with that of good wound care practice alone in pa tients with chronic lower extremity diabetic ulcers. This multicenter, evaluator-blind, parallel group, clinical trial included 172 patients with type 1 or type 2 diabetes and chronic lower extremity diabetic u lcers of at least 8 weeks' duration. Following sharp debridement of th e ulcer, patients were randomized to receive a standardized regimen of good wound care alone, good wound care plus aqueous NaCMC-based gel, or good wound care plus becaplermin gel 100 mu g/g (Regranex(R) Gel 0. 01%) until complete wound closure was achieved or for a maximum of 20 weeks. Of the patients receiving good wound care alone, 22 percent (15 /68) achieved complete wound closure at endpoint compared with 36 perc ent (25/70) of patients receiving NaCMC gel and 44 percent (15/34) of patients receiving becaplermin gel 100 mu g/g. Time to achieve complet e wound closure was shortest for the becaplermin gel 100 mu g/g group (85 days), followed by the NaCMC gel group (98 days) and longest for t he good wound care alone group (> 141 days). Adverse events reported w ere similar in nature with incidence across all treatment groups. Resu lts suggest that treatment with NaCMC aqueous-based gel did not negati vely impact and had a beneficial effect on wound healing in patients w ith chronic lower extremity diabetic ulcers. NaCMC gel and becaplernin gel 100 mu g/g were both well tolerated.