Randomised controlled trial of podoconiosis treatment in northern Ethiopia (360G-Wellcome-099946_Z_12_Z)

The overall research objective of this project is to test the effectiveness of lymphoedema management in podoconiosispatients. At present, treatment of podoconiosis lymphoedema is not routinely provided by government services anywhere inthe world. In Ethiopia, where 1 million patients are estimated to live, non-government groups have developed simple,locally-appropriate treatment based on foot hygiene, emollients, bandaging, exercises to improve lymph drainage, and useof socks and shoes. Although one small proof-of-concept study suggests effectiveness of this treatment in relation toimprovement in outcomes such as leg circumference, stage of disease and quality of life, more rigorous testing isnecessary before treatment is extended within Ethiopia and to other podoconiosis-endemic countries like Cameroon, Rwanda, Uganda and Tanzania.The more detailed objectives are -1. To test whether podoconiosis lymphoedema treatment improves clinical outcomes, including decreased frequency ofacute dermatolymphangioadenitis, reduced disease stage, reduced lower leg circumference and prevalence of interdigitalentry lesions (macerations facilitating entry to micro-organisms);2. To test whether podoconiosis lymphoedema treatment improves quality of life outcomes and perceived stigma;3. To assess whether an 'intensive' model of delivery is more effective than a 'standard' model;4. To investigate whether podoconiosis lymphoedema treatment is cost-effective and has other benefits including increasedschool attendance.This will be achieved by conducting a pragmatic, single-blind randomised controlled trial with three intervention 'arms' thatwill compare two models of podoconiosis lymphoedema management in the community with delayed treatment (as control).Nine hundred adult (aged at least 16 years) podoconiosis patients located in independent households will be randomised,300 to each arm. Twenty community project assistants will support twice-weekly treatment at community sites, and tenindependent data collectors will make monthly follow-up visits. The principal analyses will be conducted at 6 and 12 monthsof follow-up.In common with many other research projects completed by our group, the results of this trial will be rapidly disseminatedto groups positioned to act on them, including Regional and District Health Bureaux, non-government organizations andpatient associations (see Communications Plan and Impact Summary). The other vital component of this trial is thetraining and capacity building it will provide, and the objectives in these areas are -5. To develop Clinical Trials capacity in Ethiopia through training and expertise-sharing by staff of the Kilifi Clinical TrialsFacility, a group with extensive experience of clinical trials support in East Africa;6. To provide high-quality supervised post-doctoral opportunities resulting in international publications for two outstandingEthiopian researchers