Honey Experiment on LeProsy Ulcer (HELP) Study Protocol: A Randomised Control Trial of Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: A Study Protocol

Abstract

AbstractBackgroundAs in diabetes, ulcers in leprosy occur as a result of nerve damage and loss of sensation due to neuropathy. The aim of this study is to evaluate the healing properties of raw, undiluted African honey in comparison with normal saline dressing of leprosy ulcers.MethodsThis is a multi-centre, comparative, prospective, single-blinded, parallel-group, 1:1 individually randomised controlled trial to be conducted at The Leprosy Referral Hospital, Chanchaga, Niger state in central Nigeria and St. Benedict Hospital, Ogoja, Cross River state, South-south Nigeria. Raw, unadulterated honey will be used in the ulcer dressing of the eligible consenting participants in the intervention group while those in the control group will be treated by dressing with normal saline. The main outcomes will be the proportion of complete healing and the rate of healing up to 84 days post-randomisation. Follow-up will be for 6 months from randomisation. We aim to enter 90-130 participants into the study. Observations will be made by blinded observers examining photographs of ulcers.DiscussionOur study will provide an unbiased estimate of the effect of honey on the healing of neuropathic ulcers.Trial registrationISRCTN10093277. Registered on 22 December 2021.