Dermagraft Tackles Diabetic Foot Ulcers

Smith & Nephew and Advanced Tissue Sciences have reported that theirdermal replacement product, Dermagraft, is an effective treatment for hard-to-heal diabetic foot ulcers.

Looking at the overall rate of complete ulcer healing at the primary, 12-week endpoint, Dermagraft-treated patients did 21% better than controls (38.5% healing rate compared to 31.7%), but this did not achieve statistical significance (p=0.28). However, a subset of patients who received a specific "therapeutic range" of Dermagraft did do significantly better than controls, with 60% more individuals healing completely (50.8% vs 31.7%; p=0.01).

"The data clearly demonstrate that there is a therapeutic range of metabolic activity that must be present in order to optimise healing," said Gary Gentzkow, executive director of medical affairs at ATS. He noted that the new data will not affect ATS' Premarket Approval application in the USA to market the product to treat diabetic foot ulcers, but that an additional 50 patients are being enrolled "to confirm the equivalence of the Dermagraft product in this therapeutic range." Data from this confirmatory trial will be submitted as an amendment to the PMA application.