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

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.

Fish Skin Grafts Versus Alternative Wound Dressings in Wound Care: A Systematic Review of the Literature

“…A larger randomized controlled trial to assess the effectiveness of AFS grafts in comparison to collagen alginate dressings in the management of treatment-resistant DFUs was performed by Lullove et al in 2022 [ 14 ]. A total of 94 patients were included in the study and randomized into groups with either collagen alginate dressing alone or in combination with AFS grafts.…”

“…A total of 94 patients were included in the study and randomized into groups with either collagen alginate dressing alone or in combination with AFS grafts. Patients were first treated for two weeks with offloading and debridement [ 14 ]. When the patients started their treatments, the group being treated with collagen alginate dressing alone received weekly dressing changes at the clinic and three additional changes at home while patients being treated with AFS grafts received a dressing change only once every week [ 14 ].…”

“…Patients were first treated for two weeks with offloading and debridement [ 14 ]. When the patients started their treatments, the group being treated with collagen alginate dressing alone received weekly dressing changes at the clinic and three additional changes at home while patients being treated with AFS grafts received a dressing change only once every week [ 14 ]. Patients were followed for 12 weeks and the number of wound closures was recorded.…”

“…Micheal et al,Winters et al, and the studies done in 2021 and 2022 by Lullove et al found that the use of AFS grafts for the treatment of DFUs resulted in faster healing and an increased number of wound closures in comparison to the collagen alginate dressings[5,[12][13][14]. There were also no incidents of hypersensitivity reactions to the AFS grafts in any of these studies[5,[12][13][14].…”

“…Micheal et al,Winters et al, and the studies done in 2021 and 2022 by Lullove et al found that the use of AFS grafts for the treatment of DFUs resulted in faster healing and an increased number of wound closures in comparison to the collagen alginate dressings[5,[12][13][14]. There were also no incidents of hypersensitivity reactions to the AFS grafts in any of these studies[5,[12][13][14]. Winters et al particularly focused on the treatment-related costs of AFS grafts and attributed the lower costs in comparison to collagen alginate dressings to be due to the quicker healing and more complete wound closures[12].…”