Podoconiosis (Podo) Injury, Occupational Diseases, Poisoning Lymphoedema, not elsewhere classified
Conditions
Interventions
Current interventions as of 07/05/2019:
The study involves daily observed treatment with either doxycycline 200mg for 6 weeks or placebo matching doxycycline for 6 weeks (42 days). Participants with l
Sponsors
University of Buea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 07/05/2019: 1. Lymphedema of at least one leg grade 2-3 measured on a 5-point scale (Tekola et al, 2008) 2. Age = 18 years and = 60 years 3. Men or non-pregnant women. If women of childbearing potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo 4. Negative pregnancy test 5. Body weight =40 kg 6. Resident in endemic area for podoconiosis for = 2 years 7. Able and willing to give informed consent/ to provide assent to participate in the trial 8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment 9. Negative test for lymphatic filariasis (LF) Added 19/06/2025: Follow-up: 1. Participated in screening during the TAKeOFF PodoLEDoxy Cameroon clinical trial 2. Able and willing to give informed consent/to provide assent to participate in the current follow-up study Original participant inclusion criteria: 1. Lymphedema of at least one leg grade 2-4 measured on a 5-point scale (Tekola et al, 2008) 2. Age = 18 years and = 65 years 3. Men or non-pregnant women. If women of childbearing potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo 4. Negative pregnancy test 5. Body weight = 40 kg 6. Resident in endemic area for podoconiosis for = 2 years 7. Able and willing to give informed consent/ to provide assent to participate in the trial 8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment 9. Negative test for lymphatic filariasis (LF)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 07/05/2019: 1. No lymphedema 2. Stage 1, 4 or stage 5 lymphedema due to podoconiosis 3. Lymphedema due to lymphatic filariasis (LF) 4. Age 60 years 5. Body weight 2 times upper limit of normal 22. AST (GOT) > 2 times upper limit of normal 23. ALT (GPT) > 2 times upper limit of normal 24. Gamma-GT > 2 times upper limit of normal 25. Positive urine pregnancy test 26. Positive test for W. bancrofti Added 19/06/2025: Follow-up: 1. Individuals who are seriously sick at the time of study. Original participant exclusion criteria: 1. No lymphedema, stage 1 or stage 5 lymphedema due to podoconiosis 2. Lymphedema due to lymphatic filariasis (LF) 3. Age 65 years 4. Body weight 2 times upper limit of normal 21. AST (GOT) >2 times upper limit of normal 22. ALT (GPT) >2 times upper limit of normal 23. Gamma-GT >2 times upper limit of normal 24. Positive urine pregnancy test 25. Positive wb123 or TBF or qPCR for W. bancrofti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lack of progression of lymphedema due to podoconiosis (PodoLE) (stage reduction or same stage as pre-treatment using the 5-point scale staging according to Tekola et al, 2008), examined 24 months after treatment onset Added 19/06/2025: Follow-up: Level of adherence to lymphedema self-care practices since the final (24-month) evaluation in the prior PodoLEDoxy study, quantified through structured questionnaires (this will range from 2-4 years depending on the participant’s initial PodoLEDoxy enrolment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/05/2019: 1. Lack of progression of PodoLE (stage reduction or same stage as pre-treatment using the 5-point scale staging according to Tekola et al, 2008), examined 6, 12 or 18 months after treatment onset 2. Improvement of PodoLE, i.e. stage reduction (at least one stage compared to pre-treatment), examined 6, 12, 18 and 24 months after treatment onset 3. Change of PodoLE stages (reduction or increase) compared to baseline, assessed at 6, 12, 18 and 24 months after treatment onset 4. Changes (reduction or increase) of the circumference of the affected limbs compared to baseline circumferences, measured by tape measure at 6, 12, 18 and 24 months after treatment onset 5. Changes of the circumference of the affected limbs compared to baseline circumferences, measured with an infrared scanner (LymphaTech®) at 6, 12, 18 and 24 months after treatment onset 7. Changes of the volume of the affected limbs compared to baseline volume, measured with an infrared scanner (LymphaTech®) at 6, 12 and 24 months after treatment onset 8. Changes in the duration of acute attacks compared to pre-treatment, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 24 months after treatment onset 9. Changes in the frequency of acute attacks compared to pre-treatment, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 24 months after treatment onset 10. Absence of acute attacks, as assessed with a questionnaire every two months after treatment onset and evaluated at 6, 12 and 24 months after treatment onset 11. Changes of the hygiene level compared to pre-treatment, assessed by using a hygiene survey especially developed for this study at 6, 12 and 24 months 12. Changes in the quality of life (QoL) compared to pre-treatment at 12 and 24 months after treatment onset 13. Levels of angiogenic, lymphangiogenic, pro-fibrotic or pro-inflammatory biomarkers (such | — |
Countries
Cameroon
Contacts
Public ContactSamuel Wanji
Outcome results
None listed