Abstract
BackgroundLeprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. However, local nerve damage can lead to injury and consequently recurring and disfiguring ulcers. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing.MethodsThis is a single-centre study in the Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal. Consenting patients (n=130) will be individually randomised in a single-blinded, controlled trial. Participants will be 18 years of age or older, admitted to the hospital with a clean, dry and infection-free chronic foot ulcer between 2 and 20 cm2 in size. If the ulcer is infected, it will be treated before enrolment into the study. The intervention involves the application of leukocyte and platelet-rich fibrin (L-PRF) matrix on the ulcer beds during twice-weekly dressing changes. Controls receive usual care in the form of saline dressings only during their twice-weekly dressing changes. Primary outcomes are the rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow-up is at 6 months from randomisation.DiscussionThis research will provide valuable information on the clinical and cost-effectiveness of L-PRF in the treatment of leprosy ulcers. An additional benefit is the evaluation of the effects of treatment on quality of life for people living with leprosy ulcers. The results will improve our understanding of the scalability of this treatment across low-income countries for ulcer healing in leprosy and potentially other conditions such as diabetic ulcers.Trial registrationISRCTN14933421. Registered on 16 June 2020
Highlights
Background and rationale {6a} Leprosy is a chronic infectious disease that causes neuritis with loss of sensation
Neuropathy is caused primarily by inflammatory episodes called ‘reactions’, which can occur in 30–50% of leprosy cases in response to live Mycobacterium leprae or residual antigens persisting for years in skin and nerve tissues after curative treatment [1, 2]
Aim and objectives {7} The aim of this study is to evaluate the efficacy of leukocyte and platelet-rich fibrin (L-PRF) on healing rates for leprosy ulcers, time to healing and duration of hospital stay
Summary
Background and rationale {6a} Leprosy is a chronic infectious disease that causes neuritis with loss of sensation. Neuropathy is caused primarily by inflammatory episodes called ‘reactions’, which can occur in 30–50% of leprosy cases in response to live Mycobacterium leprae or residual antigens persisting for years in skin and nerve tissues after curative treatment [1, 2]. Neuritis can develop and recur at any time before, during or even years after leprosy treatment [3]. The combination of loss of sensation and deformities leads to the presentation of ulcers, often with the first presentation within 4–5 years of leprosy diagnosis, and an increased lifetime risk of recurrent ulcers, which can lead to deformity and permanent disability. Leprosy is curable with multidrug therapy and treatment in the early stages can prevent disability. The aim of this study is to evaluate the treatment of leprosy ulcers using an autologous blood product; leukocyte and platelet-rich fibrin (L-PRF) to promote healing
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