A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers

Abstract

Omega-3-rich fish skin grafts have been shown to accelerate wound healing in full-thickness wounds.The goal of this study was to compare the fish skin graft with standard of care (SOC) using collagen alginate dressing in the management of treatment-resistant diabetic foot ulcers (DFUs), defined as superficial ulcers not involving tendon capsule or bone.

Patients with diabetic foot ulcers who were first treated with standard of care (offloading, appropriate debridement, and moist wound care) for a 2-week screening period were then randomized to either receiving standard of care alone or standard of care plus fish skin graft applied weekly for up to 12 weeks. The primary endpoint was the percentage of wounds closed at 12 weeks.

Forty-nine patients were included in the final analysis. At 12 weeks, 16 of 24 patients’ diabetic foot ulcers (67%) in the fish skin arm were completely closed, compared with 8 of 25 patients’ diabetic foot ulcers (32%) in the standard of care arm. At 6 weeks, the percentage area reduction was 41.2% in the standard of care arm and 72.8% in the fish skin arm.

Conclusions: The application of fish skin graft to previously nonresponsive diabetic foot ulcers resulted in significantly more fully healed wounds at 12 weeks than standard of care alone. The study findings support the use of fish skin graft for chronic diabetic foot ulcers that do not heal with comprehensive standard of care treatment.

Source Wounds