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.
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.
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DOI：
10.1186/s13063-021-05392-5
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发表时间：
2021-07-15
期刊：
影响因子：
2.5
通讯作者：
Lilford R
中科院分区：
文献类型：
--
作者：
Napit IB;Shrestha D;Bishop J;Choudhury S;Dulal S;Gill P;Gkini E;Gwyther H;Hagge DA;Neupane K;Sartori J;Slinn G;Watson SI;Lilford R
麻风病可以通过多种药物治疗治愈，早期治疗可以预防残疾。然而，局部神经损伤可导致损伤，从而导致溃疡复发和毁容。本研究的目的是评估使用自体血制品、富含白细胞和血小板的纤维蛋白（L-PRF）治疗麻风溃疡以促进愈合。这是一项在尼泊尔加德满都尼泊尔麻风病使命Anandaban医院进行的单中心研究。将在一项单盲、对照试验中对接受治疗的患者（n=130）进行个体随机化。受试者将年满18岁，因清洁、干燥和无感染的慢性足部溃疡（2 - 20 cm 2）入院。如果溃疡被感染，将在入组研究前进行治疗。干预包括在每周两次更换敷料期间在溃疡床上应用富含白细胞和血小板的纤维蛋白（L-PRF）基质。对照组仅在每周两次敷料更换期间接受生理盐水敷料形式的常规护理。主要结果是由对分配的治疗不知情的观察者使用标准化照片评估的愈合率，以及完成上皮再形成的时间。随访时间为随机化后6个月。本研究将为L-PRF治疗麻风溃疡的临床和成本效益提供有价值的信息。另一个好处是评估治疗对麻风溃疡患者生活质量的影响。这些结果将提高我们对这种治疗在低收入国家的可扩展性的理解，用于麻风病溃疡愈合和潜在的其他疾病，如糖尿病溃疡。ClinicalTrials.govISRCTN14933421.于2020年6月16日注册
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. 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. 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. ClinicalTrials.govISRCTN14933421. Registered on 16 June 2020
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