Intact fish skin graft for deep diabetic foot ulcers: results from the KEREFISH randomized controlled trial
Authors' conclusion
In France, the addition of IFSG to the care plan of patients with deep diabetic foot wounds improved the closure rate by 41.6 % in IFSG group versus 22.2 % in SOC.
Study context
- Population
- Patients with University of Texas grade 2 and 3 Diabetic foot ulcers (DFUs), 8 centres in France179 in primary analysis
- Participants
- 180 patients
- Comparison
- Intact fish skin graft vs local standard of care
- Primary endpoint
- Complete epithelialization
- Follow-up
- 16 weeks
Methodological detailsmultinational, multicentre, French subgroup
- Multinational
- Multicentre
- French subgroup
Primary result
As reported in the abstract
Complete epithelialization (closure rate)
P = 0.0053
Secondary outcomes
- Graft applications among healed patients — Intact fish skin graft (IFSG)
- median 7 graft applications
- Mean relative wound area · week 6 · statistically significant difference · ITT analysis
- P < 0.05
Complete epithelialization · 20 weeks
- Proportion 2.11 times higher with IFSG vs standard of care (SOC)
Original publication
Intact fish skin graft for deep diabetic foot ulcers: results from the KEREFISH randomized controlled trial. Diabetes Metab. Published 23 July 2025. doi:10.
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