A Multi-center, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Fish Skin Graft in the Treatment of Chronic, Non-Responsive Diabetic Foot Ulcers

We present the first prospective multicenter randomized controlled trial evaluating the effects of Omega3 rich fish skin* for treatment of diabetic foot ulcers. Intact fish skin is a piscine dermal (xenograft) which retains its native dermal structure and a high concentration of Omega3 fatty acids.  Preclinical work has shown that the acellular native dermal structure supports cellular ingrowth, and the Omega3 fatty acids are bacteriostatic.  Early clinical work has shown efficacy in acute wounds in healthy volunteers, venous leg ulcers, mixed etiology wounds and diabetic foot ulcers.  Diabetic foot ulcers (DFUs) which do not reduce in area by fifty percent after 4 weeks of debridement and offloading are at high risk of infection and if left untreated, can lead to amputation. Intact fish skin was compared to a collagen alginate dressing** (SOC) in DFUs that were debrided and offloaded.  49 patients were included in the analysis. Median wound size (range) was SOC 2.6(1.83,6) vs fish skin graft 2.13(1,4). At 12 weeks, 67% (16/24) of the patients in the fish skin group was completely healed compared to 32% (8/25) patients in the SOC group, significant at p = 0.0152 (N=49). Of healed wounds the number of applications was not significantly different between treatment groups with avg 6.1 vs 6.3 and median 5.5 vs 6 for SOC and fish skin graft respectively. One patient in the SOC group had an infection requiring antibiotics and one patient in the fish skin graft group required an amputation of a toe unrelated to the treatment wound. The use of fish skin graft in treatment resistant DFU patients resulted in significantly improved closure rate at 12 weeks compared to SOC alone. Therefore, we find that that intact fish skin is an effective wound therapy option that should be included in the list of cellular or tissue-based products for the treatment of DFUs.