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 J. Lullove, DPM; Brock Liden, DPM; Patrick McEneaney, DPM; Allen Raphael, DPM; Robert Klein, DPM; Christopher Winters, DPM; John C. Lantis II, MD

Disclosures

Wounds. 2022;34(4):e34-e36. 

In This Article

Abstract and Introduction

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.

Introduction

In 2021, Lullove et al[1] published a planned interim report on the effect of omega-3–rich fish skin graft (FSG; Kerecis Omega3 [Kerecis]) in the management of chronic nonresponsive diabetic foot ulcers (DFUs). The anticipated completion date for patient enrollment and data acquisition was December 2021. As with many other trials, however, the timeline of this trial was significantly disrupted by COVID-19.[2] Clinical researchers have experienced unprecedented challenges, including quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, and other considerations resulting from site personnel or trial participants becoming infected with COVID-19.[2]

Therefore, the authors of the current study conducted a previously unscheduled penultimate (or unscheduled interim) analysis to follow up on the results presented by Lullove et al[1] in 2021. The premise remains that the faster the closure of a DFU, the less likely it is that the patient will progress to a minor or major amputation.[3] The authors of the current study continue to evaluate whether or not earlier wound closure affects the amputation rate. Several xenografts have been evaluated for use in the closure of DFUs. Intact FSGs have been shown to accelerate acute wound healing in full-thickness wounds compared with porcine graft[4] and human amniotic membrane.[5] The FSG is made from the skin of wild-caught Atlantic cod originating from a North Atlantic Icelandic fishery. There is no known risk of disease transmission between cold-water fish and humans, and the graft requires only mild processing, thus preserving its 3-dimensional structure and chemical composition, including omega-3 polyunsaturated fatty acids.[6,7]

This prospective, single-blind, multicenter, parallel-group, randomized controlled trial is designed to assess the efficacy of the FSG in the management of resistant DFUs that do not involve tendon or bone compared with the standard of care (SOC) using a collagen alginate dressing. This is a further evaluation of the previously reported prospective randomized controlled trial. It is important to note that this is not a second trial; rather, it is a larger analysis of the ongoing prospective trial.

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