<p>Participant baseline characteristics.</p>
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Introduction Chronic neuropathic ulcers remain a debilitating complication of leprosy, with limited evidence for effective treatments. Honey has been recommended to promote wound healing in other chronic ulcers. However, its efficacy in ulcer healing has not been rigorously evaluated. Methods This dual-centre, prospective, single-blinded, randomised controlled trial compared raw honey dressings (n = 65) versus standard saline dressings (n = 65) for leprosy-associated foot ulcers in Nigeria. Participants with ulcers (2–20 cm2, ≥ 6 weeks duration) were randomised 1:1, stratified by ulcer size. Primary outcomes were complete healing by 84 days and healing rate, assessed through blinded digital planimetry. Secondary outcomes included ulcer recurrence and/or new ulcer development at 6 months. A total of 130 participants were randomised in the study. Results Complete healing occurred in 29.2% of honey-treated ulcers versus 24.6% with saline (adjusted HR 1.26, 95% CI 0.64-2.47). At 6 months, recurrence rates were similar (honey 13.5% vs saline 10.2%). The honey group showed a non-significant trend toward faster healing (p = 0.076). No treatment-related adverse events occurred. Conclusion While honey dressings showed a modest advantage in healing rate, the difference was not statistically significant. The results suggest honey may be a safe, culturally acceptable option in resource-limited settings. This study provides high-quality data for inclusion in future systematic reviews. Trial registration ISRCTN10093277. Registered on 22 December 2021.



