Summary: In 96 adults with type 1 or 2 diabetes and hard-to-heal neuropathic foot ulcers, a standardised autologous leukocyte-poor platelet gel (RegenWound gel) was compared with standard dressings (hydrocellular or hydrocolloid) in an open-label randomised controlled trial. Complete healing at 6 weeks reached 56.5% with the gel versus 20.0% with standard care, and 77.3% versus 35.1% by 12 weeks. The published abstract reports these proportions without between-group p-values or confidence intervals, so the magnitude is suggestive rather than statistically confirmed.
PICO Summary
| Element | Detail |
|---|---|
| Population | 96 adults aged over 18 with type 1 or type 2 diabetes mellitus and hard-to-heal chronic neuropathic foot ulcers; single-country (France) randomised controlled clinical trial (ISRCTN10032417). |
| Intervention | Standardised autologous leukocyte-poor platelet gel (RegenWound gel), with an average of 1 to 2 applications needed (n = 48). |
| Comparison | Standard care dressings (hydrocellular or hydrocolloid) (n = 48). |
| Outcome | Complete healing at 6 weeks: 56.5% (gel) versus 20.0% (control); absolute difference about 36.5 percentage points, NNT approximately 3. By 12 weeks: 77.3% versus 35.1%; absolute difference about 42.2 percentage points, NNT approximately 3. The abstract reports no between-group p-values or 95% confidence intervals and no formal significance test for these proportions. The gel was reported as well tolerated and safe. |
Autologous platelet gel for diabetic foot ulcers
Open-label RCT · neuropathic DFU · 6 weeks
An autologous platelet gel healed more chronic neuropathic foot ulcers than standard dressings at 6 and 12 weeks. The open-label design and manufacturer involvement, plus absent p-values and confidence intervals, mean the benefit is suggestive rather than confirmed.
Expert Commentary
This open-label randomised controlled trial suggests that an autologous leukocyte-poor platelet gel accelerates closure of chronic neuropathic diabetic foot ulcers, with roughly half of treated patients healed by 6 weeks against one fifth on standard dressings, and the separation widening by 12 weeks. The absolute differences are large and the implied numbers needed to treat are low, which is clinically appealing in a condition where slow healing drives amputation risk. The verdict, however, must be cautious. The published abstract presents only raw healing proportions and reports no between-group p-values or confidence intervals, so the apparent benefit has not been shown to reach conventional statistical significance and the precision around it is unknown. The most important limitation is the combination of an unavoidably unblinded design, with an applied gel compared against a passive dressing, and manufacturer involvement: two authors are affiliated with the company that produces RegenWound gel, which raises the possibility of optimistic ascertainment of an outcome as subjective as wound closure. The single-country, modest sample further limits generalisability. Can I use this with my patients? Not yet on this evidence alone, though it is a reasonable option to consider within a specialist podiatry pathway for selected hard-to-heal ulcers that have failed standard care. I would want an independently funded, adjudicator-blinded trial reporting effect estimates with confidence intervals before recommending it routinely.
References
Clavel S, Denizot C, Boëzennec B, Turzi A, Albache N. A randomised controlled clinical study comparing the efficacy and safety of an autologous standardised leukocyte-poor platelet gel with standard care for the treatment of chronic neuropathic diabetic foot ulcers. Int Wound J. 2025;22(4):e70495. doi:10.1111/iwj.70495