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

Conditions

Podoconiosis (non-filarial elephantiasis) Circulatory System Lymphoedema, not elsewhere classified

Astrid C. Erber, Victoria Ewing, M. Turner, Meseret Derbew Molla, Gharib Murbe et al. (7 authors)

European Journal of Public Health2021-10-01

Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia

Astrid C. Erber, Victoria Ewing, M. Turner, Meseret Derbew Molla, Gharib Murbe et al. (8 authors)

PLoS neglected tropical diseases2021-07-288 citations

10.1371/journal.pntd.0009582

Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.

Negussie H, Molla M, Ngari M, Berkley JA, Kivaya E, Njuguna P, Fegan G, Tamiru A, Kelemework A, Lang T, Newport MJ, McKay A, Enquoselassie F, Davey G.

2018-05-1558 citations

10.1016/s2214-109x(18)30124-4

Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia.

Molla M, Negussie H, Ngari M, Kivaya E, Njuguna P, Enqueselassie F, Berkley JA, Davey G.

2018-03-075 citations

10.1186/s12874-018-0486-x

Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial

Henok Negussie, Meseret Molla Kassahun, Greg Fegan, Patricia Njuguna, Fikre Enquselassie et al. (9 authors)

Trials2015-07-1526 citations

10.1186/s13063-015-0818-7

Interventions

Standard podoconiosis lymphoedema management in the community with delayed treatment (as control). Standard podoconiosis lymphoedema management consisting of twice-weekly group meetin

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of acute dermatolymphangioadenitis (ADLA). Mean number of ADLA episodes over 12 months.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Ethiopia

Outcome results

None listed