GoLBet Trial

Summary

Background and study aims

Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Although an estimated 4 million people are affected by podoconiosis across Africa, there is no government health service provision for patients in countries where it is found. In Ethiopia, where 1 million people with podoconiosis live, non-government organizations (NGOs) have developed simple treatments using low-cost, locally available materials. Treatment includes foot hygiene, skin care, bandaging, exercises to improve lymph drainage and use of socks and shoes. Although the NGOs consider the treatment to be effective, no study has been done to prove that it is.

Our main aim is to test whether the 'standard' treatment reduces the number of times a patient experiences 'acute episodes', when the leg become hot, painful and more swollen than usual. These episodes significantly interfere with patients' ability to work or carry out normal day-to-day tasks. We will also measure the cost of the treatment and gather information on the economic effects of untreated disease (for example loss of earnings due to inability to work).

This trial is registered with the Current Controlled Trials ISRCTN67805210.

researchers

Principal Investigator

Dr Gail Davey

Trial Coordinator

Henok Negussie

Data Manager

Meseret Molla

contact trials@podo.org for more information.

Collaborators

Dr Fikre Enquosellasie Gashe (School of Public Health, Addis Ababa University, Ethiopia)

Dr Trudie Lang (Director, Global Health Trials Network, and Oxford Centre for Tropical Medicine)

Prof Andy McKay (School of Business, Management and Economics, University of Sussex)

Prof Melanie Newport (Brighton & Sussex Medical School)

Gojjam Lymphoedema Best practice Trial: A study of the effectiveness of treatment for podoconiosis

GolBet study updates

Image: Patients starting treatment in Yewobi

After several months of screening and recruitment, we are happy to share that the trial has now been successfully completed.

The database is locked, and articles are being submitted for publication.

If you would like to request access to the database please write to
globalhealth@bsms.ac.uk or g.davey@bsms.ac.uk

what does the study involve?

690 podoconiosis patients have been allocated to one of two groups: either to 'standard' treatment, or to 'delayed' treatment (i.e. 345 patients in each group). Standard treatment consists of soaking the feet in dilute antiseptic and washing them with soap and water. Moisturising lotion is then applied to the skin and the feet and lower legs are bandaged. This is done every day and will continue throughout the year. Patients attend meetings to learn how to do it. Treatment is organised through the International Orthodox Christian Charities (IOCC) Podoconiosis Project, which  has excellent links with the community and local government. The delayed treatment group will receive no treatment for one year, but will receive treatment at the end of the study. The number of acute episodes will be compared between the two groups.

who can participate?

Men and women who have podoconiosis and are at least 16 years old and who will remain living in the study area for the length of the study.

benefits and risks

Patients allocated to the treatment group will benefit from the treatment they receive for their podoconiosis. Patients allocated to the control arm (delayed treatment) will receive treatment after the study has been completed. Although this means a delay in receiving treatment, only about 3% of patients can access treatment in Ethiopia so most people with podoconiosis receive no treatment, at the moment. Possible risks include adverse effects from inexperienced bandaging: this will be mitigated by careful training of project assistants.

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