Condition category
Circulatory System
Date applied
16/01/2013
Date assigned
24/01/2013
Last edited
04/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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. 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 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

Trial website

http://www.podo.org/research/current/golbet-trial/

Contact information

Type

Scientific

Primary contact

Dr Gail Davey

ORCID ID

http://orcid.org/0000-0003-2796-7468

Contact details

Brighton & Sussex Medical School
BSMS Teaching Building Rm 2.16
University of Sussex
Falmer
Brighton
BN1 9PX
United Kingdom
+44 (0)1273 872528
g.davey@bsms.ac.uk

Type

Scientific

Additional contact

Ms Debbie Miller

ORCID ID

Contact details

Global Health & Infection
Brighton & Sussex Medical School
Brighton
BN1 9PX
United Kingdom
+44 (0)1273 877889
Global-Health-Research-Administrator@bsms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of podoconiosis treatment in northern Ethiopia

Acronym

GoLBeT

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: there will be no difference in outcome between standard and delayed treatment groups.

Ethics approval

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

Study design

Pragmatic single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Podoconiosis (non-filarial elephantiasis)

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of acute dermatolymphangioadenitis (ADLA). Mean number of ADLA episodes over 12 months.

Secondary outcome measures

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)
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 trial start date

01/12/2013

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

690

Participant 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 to treatment
4. Physical disability beyond that of podoconiosis precluding attendance at group sessions

Recruitment start date

03/11/2014

Recruitment end date

15/06/2015

Locations

Countries of recruitment

Ethiopia

Trial participating centre

International Orthodox Christian Charities
Addis Ababa
-
Ethiopia

Trial participating centre

Addis Ababa University
King George VI St
Addis Ababa
1000
Ethiopia

Trial participating centre

Kilifi Clinical Trial Facility
Kilifi
-
Kenya

Sponsor information

Organisation

University of Sussex (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.sussex.ac.uk/

Funders

Funder type

Research council

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Wellcome Trust - scheme to fund global health clinical trials (MR/K007211/1)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A 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 submitted by the end of April 2017.

IPD sharing plan
The 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.

Intention to publish date

01/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26177812

Publication citations

Additional files

Editorial Notes

03/11/2016: the overall trial end date was changed from 30/11/2015 to 31/05/2017.