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| [ Print-friendly version ] |
| GoLBeT [Gojjam Lymphoedema Best practice Trial]: A study of the effectiveness of treatment for podoconiosis (non-filarial elephantiasis) |
| ISRCTN | ISRCTN67805210 |
| DOI | 10.1186/ISRCTN67805210 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | GoLBeT [Gojjam Lymphoedema Best practice Trial]: A study of the effectiveness of treatment for podoconiosis (non-filarial elephantiasis) |
| Scientific title | Randomised controlled trial of podoconiosis treatment in northern Ethiopia |
| Acronym | GoLBeT |
| Serial number at source | N/A |
| Study hypothesis |
Golbet means ‘be strong’ in Amharic.
Standard community-based treatment of podoconiosis lymphoedema improves individual clinical, social and economic outcomes for people with podoconiosis. Null hypothesis: is that there will be no difference in outcome between standard and delayed treatment groups. |
| Lay 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). 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. What does the study involve? Before the study, a survey will be done to collect background information on typical work hours and settings, labour and medical costs and productivity losses related to podoconiosis. We will also do a rapid assessment to identify the best methods of giving information about the study and the approaches to obtaining informed consent preferred by the community. We will allocate 690 podoconiosis patients to one of two groups: either to ‘standard’ treatment, or to delayed treatment (i.e. 345 patients in each group). Standard treatment will consist of soaking the feet in dilute antiseptic and washing them with soap and water. Moisturising lotion will then be applied to the skin and the feet and lower legs will be bandaged. This will be done every day for one year and patients will attend meetings to learn how to do it. Treatment will be organised through the International Orthodox Christian Charities (IOCC) Podoconiosis Project, which already 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. What are the possible benefits and risks of taking part? 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. Where is the study run from? The study will be based at the IOCC Debre Markos Podoconiosis Project in East Gojjam Zone, Amhara Region, northern Ethiopia, where podoconiosis is very common. Brighton and Sussex Medical School and the Clinical Trial Facility at the KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya will provide support for the study. When is the study starting and how long will it run for? The study will start recruiting from Oct till December 2013 and intervention be applied from Jan 2014 for 1 year. Who is funding the study? The study is funded by Medical Research Council (MRC)/ UK Department for International Development (DfID)/Wellcome Trust. Who is the main contact? Dr Gail Davey, g.davey@bsms.ac.uk Professor Melanie Newport, m.j.newport@bsms.ac.uk |
| Ethics approval |
Approval pending as of 17/01/2013:
Ethiopia: Addis Abbaba University Institutional Review Board Amhara Regional Health Institutional Review Board Ethiopia National Ethics Review Board UK: Brighton and Sussex Medical School’s Research Governance and Ethics Committee |
| Study design | Pragmatic single-blind randomized controlled trial |
| Countries of recruitment | Ethiopia |
| Disease/condition/study domain | Podoconiosis (non-filarial elephantiasis) |
| Participants - inclusion criteria |
1. Patients (male and female) must be at least 16 years old
2. Have a diagnosis of podoconiosis confirmed by the trial team 3. Not be planning to move away from the area during the study period |
| Participants - exclusion criteria |
1. Lymphoedema of causes other than podoconiosis
2. History of allergic reaction to treatment materials 3. Mental health disorder affecting ability to adhere with treatment 4. Physical disability beyond that of podoconiosis precluding attendance at group sessions |
| Anticipated start date | 01/12/2013 |
| Anticipated end date | 30/11/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 690 |
| Interventions |
Standard podoconiosis lymphoedema management in the community with delayed treatment (as control).
Standard podoconiosis lymphoedema management consisting of twice-weekly group meetings with instruction and practical demonstration of foot hygiene by a community project assistant. Foot hygiene comprises: soaking feet in dilute antiseptic, washing with soap, rinsing with clean water, drying and application of emollient; supervised use of normal or short-stretch bandages for disease stage ≥3; foot elevation and exercises; instruction to practice foot hygiene daily at home; instruction to elevate the foot of the bed or areas slept on; instruction to acquire socks and shoes where possible. |
| Primary outcome measure(s) | Incidence of acute dermatolymphangioadenitis (ADLA). Mean number of ADLA episodes over 12 months. |
| Secondary outcome measure(s) |
1. Adherence with treatment (foot washing, use of ointment, use of bandages, elevation, exercises, use of socks and shoes)
2. Clinical stage of disease (using scale specifically developed for use in podoconiosis patients, lower leg and foot circumferences (measured in cm at mid-calf and mid-foot) 3. Presence of mossy changes, wounds and inter-digital entry lesions 4. Duration of ADLA (days) 5. Quality of life (using validated Amharic translation of Dermatology Life Quality Index) 6. Perceived stigma (using recently developed scale for measuring stigma among podoconiosis patients) 7. Economic productivity (days/part-days off work) |
| Sources of funding |
1. UK Department for International Development (DFID) (UK)
2. Medical Research Council (MRC) (UK) 3. Wellcome Trust (UK) - scheme to fund global health clinical trials (MR/K007211/1) |
| Trial website | http://www.podo.org/research/current/golbet-trial/ |
| Publications | |
| Contact name | Dr Gail Davey |
| Address |
Brighton & Sussex Medical School
BSMS Teaching Building Rm 2.16 University of Sussex Falmer |
| City/town | Brighton |
| Zip/Postcode | BN1 9PX |
| Country | United Kingdom |
| Tel | +44 (0)1273 872528 |
| g.davey@bsms.ac.uk | |
| Sponsor | University of Sussex (UK) |
| Address |
Sussex House
Southern Ring Road Falmer |
| City/town | Brighton |
| Zip/Postcode | BN1 9RH |
| Country | United Kingdom |
| Sponsor website: | http://www.sussex.ac.uk/ |
| Date applied | 16/01/2013 |
| Last edited | 05/03/2013 |
| Date ISRCTN assigned | 24/01/2013 |
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