Safety evaluation of bi‐layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers— SAFESKIN ‐ DFU : A Phase 1 clinical trial
Authors' conclusion
The application of a bi-layered allogeneic keratinocyte and fibroblast skin substitute in patients with chronic DFU was safe and associated with favourable wound healing results. Adherence to standard treatment protocols, including optimal offloading, is essential to maximize the likelihood of successful wound healing.
Study context
- Population
- Patients with chronic diabetic foot ulcers (DFUs)
- Participants
- 5 patients
- Outcome
- Safety and efficacy (adverse effects and wound improvement)
- Follow-up
- 6 months
Methodological detailssingle-arm
- Single-arm
Main finding
As reported in the abstract
Significant reduction in wound size during initial 12-week treatment phase
4 patients
Complete closure at 24 weeks
2 patients
Safety
- Overall safe; only few adverse effects, unrelated to the product
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Safety evaluation of bi‐layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers— SAFESKIN ‐ DFU : A Phase 1 clinical trial. Diabetes Obes Metab. Published 19 August 2024. doi:10.
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