Intact Fish Skin Graft Outperforms Standard Care in Healing Deep Diabetic Foot Ulcers: Study Reveals
France: Recent research published in NEJM Evidence has revealed that using intact fish skin grafts is significantly more effective than standard care in treating deep diabetic foot ulcers. This innovative approach enhances the rate of wound healing and accelerates the healing process, offering new hope for patients battling this challenging condition.
Diabetic foot ulcers are a common complication for individuals with diabetes, often leading to serious infections and, in severe cases, amputations. Traditional treatment methods, which typically involve standard dressings and wound care, have shown limited effectiveness, prompting healthcare professionals to explore alternative therapies. The introduction of intact fish skin grafts has emerged as a promising solution. Considering this, Dured Dardari, Diabetology Department, Center Hopitalier Sud Francilien, Corbeil-Essonnes, France, and colleagues aimed to evaluate the effectiveness of intact fish skin grafts compared to standard care in promoting wound healing and reducing healing time in patients with deep diabetic foot ulcers.
For this purpose, the researchers conducted an international, open-label randomized controlled trial, in which patients with diabetic ulcers penetrating to bone, joint, or tendon were randomly assigned in a 1:1 ratio to receive either intact fish skin grafts or standard wound care. The assigned treatment was applied for 14 weeks.
The primary endpoint was the proportion of ulcers healed at 16 weeks, defined as reepithelialization identified by the investigator and confirmed 14 days later. Healing assessments were also conducted at 20 and 24 weeks, with confirmation of healing at both time points carried out by a blinded adjudication committee.
Based on the study, the researchers revealed the following findings:
- Between July 2020 and November 2022, 255 patients were randomly assigned to receive either intact fish skin grafts (n=129) or standard care (n=126).
- At the 16-week mark, healing was observed in 44% of patients treated with intact fish skin grafts, compared to 26% in the standard care group.
- Additional healing rates were noted at 20 weeks (46% versus 32%) and 24 weeks (55% versus 38%).
- The mean time to healing was 17.3 weeks for the intact fish skin graft group, while it was 19.4 weeks for the standard care group.
- A Cox regression analysis indicated that treatment with intact fish skin grafts was associated with a faster time to healing, with a hazard ratio of 1.59.
- The most common adverse event was primary wound infections, which occurred in 30.2% of patients in the intact fish skin graft group and 24.6% in the standard care group.
"The findings showed that in patients with deep diabetic foot ulcers, treatment with intact fish skin grafts was more effective than standard care, resulting in a higher proportion of healed wounds at 16 weeks and a quicker healing time," the researchers concluded.
Reference:
Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Oct 4:EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub ahead of print. PMID: 39365895.
