Efficacy of topical polypeptide gel in accelerating early healing of diabetic ulcers: a randomized controlled trial

Diabetic ulcer (DU) remains a major health problem with high morbidity and treatment cost. Effective, rapid, and affordable treatment is essential for its management. Topical polypeptide gel has regenerative, angiogenic, and anti-inflammatory properties that may accelerate wound healing. However, clinical evidence regarding effectiveness is limited.

A double-blinded randomized controlled trial was conducted involving 26 subjects with DU, randomly allocated into an intervention group that received 7% topical polypeptide and a control group that received hydrocolloid gel. Wound healing was assessed by measuring ulcer surface area reduction on days 7, 14, and 21 compared to baseline.

The polypeptide gel group demonstrated significantly greater absolute ulcer size reduction on day 7 (p = 0.002) and day 14 (p = 0.004), whereas the difference in absolute area did not reach statistical significance on day 21 (p = 0.106). When healing was expressed as the percentage of wound reduction from baseline, the polypeptide gel group showed significantly greater wound closure at all three time points, including day 21 (day 7: 66.4% vs. 16.8%, p < 0.001; day 14: 83.3% vs. 27.8%, p < 0.001; day 21: 92.7% vs. 41.5%, p = 0.002), with large effect sizes.

Topical 7% polypeptide gel was associated with significantly greater reduction in diabetic ulcer surface area compared with hydrocolloid gel. Although the difference in absolute area reduction did not reach statistical significance at day 21, the relative reduction from baseline remained significantly greater in the polypeptide gel group at all three time points, indicating a sustained healing advantage.