02734nas a2200265   4500000000100000008004100001260003300042100001200075700001500087700001300102700001600115700001200131700001200143700001200155700001500167700001200182700001400194700001400208700001200222700001400234700001400248245018900262856009800451520191900549       2021                            d  bResearch Square Platform LLC1 aNapit I1 aShrestha D1 aBishop J1 aChoudhury S1 aDulal S1 aGill PS1 aGkini E1 aGwyther HE1 aHagge D1 aNeupane K1 aSartori J1 aSlinn G1 aWatson SL1 aLilford R00aAn individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal: the TABLE trial protocol  uhttps://assets.researchsquare.com/files/rs-267472/v1/1d4cee1c-8fda-4aa8-95c8-44a3d6ddac32.pdf3 a<jats:title>Abstract</jats:title>
        <jats:p>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 hospital with a clean, dry and infection free chronic plantar foot ulcer between 2 and 20 cm<jats:sup>2</jats:sup> 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 rate of healing assessed using standardised photographs by observers blind to allocated treatment, and time to complete re-epithelialization. Follow up is at six 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. Date of trial registration: 16 June 2020</jats:p>