Evaluating the Effect of Omega-3–rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers: Penultimate Analysis of a Multicenter, Prospective, Randomized Controlled Trial
Eric Lullove, Brock Liden, Patrick A. McEneaney, Allen Raphael, Robert S. Klein, Christopher Winters, John C Lantis
Abstract
OBJECTIVE: This is the second of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial assessing the efficacy of fish skin graft in the management of diabetic foot ulcers in comparison with the standard of care (collagen alginate dressing). MATERIALS AND METHODS: The primary end point of this prospective randomized trial is the number of closed wounds at 12 weeks. RESULTS: As of the time of this writing, 94 patients had completed the protocol. At 12-week follow-up, healing was achieved in 63.0% of index ulcers (29 of 46 patients) in the acellular fish skin graft group compared with 31.3% in the control group (15 of 48 patients) (P =.0036). In both groups, the mean time to healing was 7 weeks. The median number of applications of the fish skin graft to achieve healing was 6. CONCLUSION: A clinically and statistically significant difference in healing was observed between patients treated with acellular fish skin graft and those treated with a collagen alginate dressing. The data support the completion of this prospective randomized trial.