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

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.