An 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

Abstract

Background Leprosy 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. Methods This 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. Discussion This 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 registration ClinicalTrials.govISRCTN14933421. Registered on 16 June 2020

A randomised Trial of Autologous Blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in LEprosy: The TABLE trial

“…TABLE was a two-arm parallel individually randomised controlled trial with blinded outcome assessment conducted at the Anandaban Hospital, The Leprosy Mission Nepal in Kathmandu. The protocol for the trial has been published [ 31 ].…”

“…The intervention involved application of Leukocyte and Platelet-Rich Fibrin (L-PRF) matrices, prepared using the participant’s own blood, and applied to the ulcer bed. This method has been in routine use at Anandaban Hospital for many years and has been described in detail [ 31 ]. In brief, up to 80 ml of the participant’s blood (depending on the size of ulcer) was collected twice per week at the time of routine dressing change carried out in a minor operating room.…”

“…For this reason, outcomes at 42 days are the main outcomes in the trial. At this point it was predicted that about 70% of ulcers would have healed [ 31 ].…”

“…Platelet Rich blood products in the forms of L-PRF or PRP have been recently widely used in the treatment of chronic neuropathic ulcers in Leprosy [ 27 ]. There were only two presentations about the L-PRF/PRP in wound healing in International Leprosy Congress (ILC)-2019 in Manila -one about the application of L-PRF in leprosy foot ulcers [ 28 ] and another about the role of PRP in diabetic and leprosy foot ulcers [ 29 ], whereas there were 8 papers (7 oral papers and one e-poster paper) about the use of L-PRF/PRP in leprosy foot ulcers presented at ILC-2022 in Hyderabad, India [ 30 ]. We used L-PRF gel that is rich in factors including platelet-derived growth factors (PDGF), vascular endothelial growth factors (VEGF) and epidermal growth factors (EGF).…”

Raw, Unadulterated African Honey for Ulcer Healing in Leprosy: Protocol for the Honey Experiment on Leprosy Ulcer (HELP) Randomized Controlled Trial

“…A total of 30% to 50% of people infected with leprosy globally are reported to eventually have nerve damage or neuropathy [ 5 ]. Ulcers usually occur in anesthetic feet and will heal slowly with routine therapy; however, they have a tendency to recur [ 6 ].…”