GoLBeT [Gojjam Lymphoedema Best practice Trial]: a study of the effectiveness of treatment for podoconiosis (non-filarial elephantiasis)

ISRCTN ISRCTN67805210
DOI https://doi.org/10.1186/ISRCTN67805210
Secondary identifying numbers N/A
Submission date
16/01/2013
Registration date
24/01/2013
Last edited
29/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English 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. The aim of this study 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. The cost of the treatment will also be measured and information gathered 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 October until December 2013 and the intervention be applied from January 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

Study website

Contact information

Dr Gail Davey
Scientific

Brighton & Sussex Medical School
BSMS Teaching Building Rm 2.16
University of Sussex
Falmer
Brighton
BN1 9PX
United Kingdom

ORCiD logoORCID ID 0000-0003-2796-7468
Phone +44 (0)1273 872528
Email g.davey@bsms.ac.uk
Ms Debbie Miller
Scientific

Global Health & Infection
Brighton & Sussex Medical School
Brighton
BN1 9PX
United Kingdom

Phone +44 (0)1273 877889
Email Global-Health-Research-Administrator@bsms.ac.uk

Study information

Study designPragmatic single-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRandomised controlled trial of podoconiosis treatment in northern Ethiopia
Study acronymGoLBeT
Study hypothesisGolbet 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: there will be no difference in outcome between standard and delayed treatment groups.
Ethics approval(s)1. Research Governance and Ethics Committee of Brighton & Sussex Medical School, 12/08/2014, ref: 13/107/DAV
2. College of Health Sciences, Addis Ababa University, 12/12/2013, ref: 071/13/SPH
3. Ethiopian Food, Medicine and Health Care Administration and Control Authority, 09/04/2014, ref: 02/6-1/05/39
4. National Research Ethics Review Committee of the Ministries of Health and Science and Technology of Ethiopia, 11/07/2014, ref: 3-1/794/06
ConditionPodoconiosis (non-filarial elephantiasis)
InterventionStandard 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.
Intervention typeOther
Primary outcome measureIncidence of acute dermatolymphangioadenitis (ADLA). Mean number of ADLA episodes over 12 months.
Secondary outcome measures1. 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)
3. Lower leg and foot circumferences (measured in cm at mid-calf and mid-foot)
4. Presence of mossy changes, wounds and inter-digital entry lesions
5. Duration of ADLA (days)
6. Quality of life (using validated Amharic translation of Dermatology Life Quality Index)
7. Perceived stigma (using recently developed scale for measuring stigma among podoconiosis patients)
8. Economic productivity (days/part-days off work)
Overall study start date01/12/2013
Overall study end date31/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants690
Participant inclusion criteria1. 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
Participant exclusion criteria1. Lymphoedema of causes other than podoconiosis
2. History of allergic reaction to treatment materials
3. Mental health disorder affecting ability to adhere to treatment
4. Physical disability beyond that of podoconiosis precluding attendance at group sessions
Recruitment start date03/11/2014
Recruitment end date15/06/2015

Locations

Countries of recruitment

  • Ethiopia
  • Kenya

Study participating centres

International Orthodox Christian Charities
Addis Ababa
-
Ethiopia
Addis Ababa University
King George VI St
Addis Ababa
1000
Ethiopia
Kilifi Clinical Trial Facility
Kilifi
-
Kenya

Sponsor information

University of Sussex (UK)
University/education

Sussex House
Southern Ring Road
Falmer
Brighton
BN1 9RH
England
United Kingdom

Website http://www.sussex.ac.uk/
ROR logo "ROR" https://ror.org/00ayhx656

Funders

Funder type

Research council

Department for International Development
Government organisation / National government
Alternative name(s)
Department for International Development, UK, DFID
Location
United Kingdom
Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
Wellcome Trust - scheme to fund global health clinical trials (MR/K007211/1)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date01/01/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planA dissemination workshop will be held in May 2017 either in Addis Ababa or in Bahir Dar (the regional capital), depending on security at the time. The primary outcome manuscript will be published by January 2018.
IPD sharing planThe Data Sharing Policy encourages scientists to apply for use of the dataset once a period of a year after the close of the trial has elapsed (during which the trial team will have exclusive use). The datasets are available from Debbie Miller (Global-Health-Research-Administrator@bsms.ac.uk) on reasonable request.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 16/07/2015 Yes No
Results article results 01/07/2018 Yes No
Results article results 01/12/2018 Yes No
Other publications Qualitative assessment of trial 28/07/2021 29/07/2021 Yes No

Editorial Notes

29/07/2021: Publication reference added.
16/04/2019: Internal review.
12/03/2019: Publication reference added.
21/05/2018: Publication reference added.
11/10/2017: Intention to publish date changed from 01/04/2017 to 01/01/2018.
03/11/2016: Overall trial end date changed from 30/11/2015 to 31/05/2017.