Platelet-Rich Plasma Fibrin Glue Dressing Combined with a Novel Repairing Gel for Healing Recalcitrant Diabetic Foot...

Recalcitrant diabetic foot ulcers (DFUs) remain difficult to heal and impose substantial clinical and economic burdens. This exploratory, four-arm, parallel-group randomized pilot trial aimed to evaluate whether combining platelet-rich plasma-fibrin glue (PRP‑FG) with a novel repairing gel enhances healing outcomes in DFUs compared with standard care and single‑agent therapies.

In this study, twenty patients with DFUs unresponsive to at least four weeks of standard treatment were randomized using computer-generated blocks with allocation concealment to receive PRP‑FG alone, repairing gel alone, the combination therapy, or standard care. Allogeneic PRP‑FG was prepared by gradient‑density centrifugation. The repairing gel contained multiple active components, including vitamins A, B3, and C, collagen, glycine, organic acids, sodium alginate, carboxymethyl cellulose, benzoic acid, gentian violet, methylene blue, triethanolamine, bromelain, allantoin, and dimethyl sulfoxide. Wound healing rate over 12 weeks served as the primary outcome, assessed weekly by a blinded evaluator.

Nineteen patients completed the 12‑week follow‑up. Complete epithelialization occurred in 100% (5/5) of participants receiving the combined therapy, 20% (1/5) of those receiving the repairing gel alone, and 0% (0/5) in the PRP‑FG alone and standard care groups. The combined therapy significantly accelerated ulcer healing compared with all other groups (p < 0.05). These findings are preliminary and derived from a small pilot sample. No serious adverse events were observed.

This exploratory pilot trial suggests that combined PRP‑FG and repairing gel therapy may promote superior healing of recalcitrant DFUs compared with standard care or single‑agent treatments. Larger, multicenter clinical trials are warranted to validate these preliminary findings.