Diabetic Foot Ulcers: Penultimate Analysis of a Multicenter, Prospective, Randomized Controlled Trial
Eric J. Lullove, Brock Liden, Patrick McEneaney, Allen Raphael, Robert Klein, Christopher Winters, John C Lantis II
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 … read more