title: Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes.
  
  
  METHODS
  This is a pragmatic, individually randomised controlled trial. We plan to randomly allocate 680 podoconiosis patients from the East Gojjam Zone in northern Ethiopia to one of two groups: 'Standard Treatment' or 'Delayed Treatment'. Those randomised to standard treatment will receive the hygiene and foot-care intervention from May 2015 for one year, whereas those in the control arm will be followed through 2015 and be offered the intervention in 2016. The trial will be preceded by an economic context survey and a Rapid Ethical Assessment to identify optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community. The primary outcome will be measured by recording patient recall and using a simple, patient-held diary that will be developed to record episodes of acute attacks. Adherence to treatment, clinical stage of disease, quality of life, disability and stigma will be considered secondary outcome measures. Other outcomes will include adverse events and economic productivity. Assessments will be made at baseline and at 3, 6, 9 and 12 months thereafter.
  
  
  CONCLUSIONS
  The evidence is highly likely to inform implementation of the new master plan for integrated control of Neglected Tropical Diseases (NTDs), in which podoconiosis is identified as one of eight NTDs prioritised for control. Potentially, an estimated 3 million patients in Ethiopia will therefore benefit from the results of this trial.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number.
  
  
  BACKGROUND
  ISRCTN67805210. Date of registration: 24 January 2013.
authors.affiliation: Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. H.Seifu@bsms.ac.uk.
authors.forename: Henok
authors.initials: H
authors.lastname: Negussie
authors.affiliation: College of Development Studies, Addis Ababa University, Addis Ababa, Ethiopia. mesenana_03@yahoo.com.|Department of Statistics, University of Gondar, Gondar, Ethiopia. mesenana_03@yahoo.com.
authors.forename: Meseret Molla
authors.initials: MM
authors.lastname: Kassahun
authors.affiliation: Oxford University Centre for Tropical Medicine, Oxford, UK. GFegan@kemri-wellcome.org.|Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. GFegan@kemri-wellcome.org.
authors.forename: Greg
authors.initials: G
authors.lastname: Fegan
authors.affiliation: Kenya Medical Research Institute-Wellcome Trust Research Programme (KWTRP), Kilifi, Kenya. PNjuguna@kemri-wellcome.org.
authors.forename: Patricia
authors.initials: P
authors.lastname: Njuguna
authors.affiliation: School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. fikreens@yahoo.com.
authors.forename: Fikre
authors.initials: F
authors.lastname: Enquselassie
authors.affiliation: Department of Economics, University of Sussex, Falmer, Brighton, BN1 9SL, UK. A.Mckay@sussex.ac.uk.
authors.forename: Andy
authors.initials: A
authors.lastname: McKay
authors.affiliation: Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. M.J.Newport@bsms.ac.uk.
authors.forename: Melanie
authors.initials: M
authors.lastname: Newport
authors.affiliation: Oxford University Centre for Tropical Medicine, Oxford, UK. trudie.lang@ndm.ox.ac.uk.
authors.forename: Trudie
authors.initials: T
authors.lastname: Lang
authors.affiliation: Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. G.Davey@bsms.ac.uk.
authors.forename: Gail
authors.initials: G
authors.lastname: Davey
mesh_terms: D000208:Acute Disease; D001458:Bandages; D002985:Clinical Protocols; D017281:Cost of Illness; D004185:Disability Evaluation; D004604:Elephantiasis / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005002:Ethiopia; D005081:Exercise Therapy; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006920:Hygiene; D007258:Informed Consent; D058069:Neglected Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010349:Patient Compliance; D010353:Patient Education as Topic; D011287:Prejudice / Q000523:psychology; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D057566:Self Report; D012720:Severity of Illness Index; D012775:Shoes; D013240:Stereotyping; D013997:Time Factors; D061665:Time-to-Treatment; D016896:Treatment Outcome