Chronic Lymphoedema due to Lymphatic Filariasis
Conditions
Interventions
Study Settings (Sri Lanka): Galle and Matara Districts
Snowball sampling method will be used to complete recruitment.
Study design:
This (LEDOXY-SL) trial is designed as a randomized, controlled, observer-, provider- and patient-blinded multicenter supe
Late Grade 4-6). Randomization will be performed as block randomization within each center in blocks of (N=4-10) for each of the groups (early and late).
Intervention
Intervention arm will receive
Sponsors
Task Force for Global Health
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 14 years and 40 kg 5. Lymphedema of a limb Grade 1-6 measured on a 7-point scale (Dreyer G et al. 2002). 6. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment 7. No evidence of severe or systemic co-morbidities except for features of filarial disease 8. Normal laboratory profile 9. Consent to storage of blood samples for study
Exclusion criteria
Exclusion criteria: 1. No lymphedema or lymphedema stage 7 2. Age 65 years 3. Body weight < 40 kg 4. Pregnant or breastfeeding women 5. Women of childbearing potential not using an agreed method of contraception. (A pregnancy test will be conducted as part of the screening process to exclude pregnancy and repeated at 3 and 8 weeks. In addition, women of childbearing potential will be counseled against pregnancy during the treatment period) 6. Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease 7. Alcohol or drug abuse 8. History of adverse reactions to doxycycline or other tetracyclines 9. Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator 10. Chronic headache and current headache 11. Persons who are currently taking doxycycline for other indications 12. Lymphedema due to post-radiation, post-surgical and primary (congenital) lymphedema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lymphedema grade at 24 months compared to baseline [At baseline and 24 months after commencement of the intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement or halt of progression (Lack of progression) of LE when examined 12 months after treatment onset [At baseline, 12 months and 24 months after commencement of the intervention] Improvement of LE when examined 12 and 24 months after treatment onset [At baseline, 12 months and 24 months after commencement of the intervention] Change of LE stages (reduction or increase) compared to baseline assessed at 12 and 24 months [At baseline, 12 months and 24 months after commencement of the intervention ] Change in the circumference of the affected limb from baseline [At baseline, 12 months and 24 months after commencement of the intervention ] Change in circumference through Lymphatech 3D-camera measurement compared to baseline [At baseline, 12 months and 24 months after commencement of the intervention ] Change in volume through Lymphatech 3D-camera measurements compared to baseline [At baseline, 12 months and 24 months after commencement of the intervention ] Reduction in the frequency of acute ADLA attacks evaluated from 0-12 months and from 12-24 months after treatment onset [At baseline, 12 months and 24 months after commencement of the intervention ] Changes in skin thickness at 12 and 24 months compared to the baseline [At baseline, 12 months and 24 months after commencement of the intervention ] Change in angiogenic, pro-fibrotic or pro-inflammatory biomarkers at 12 and 24 months following doxycycline administration (at sites where these tests are done) [At baseline, 12 months and 24 months after commencement of the intervention ] | — |
Countries
Sri Lanka
Contacts
Public ContactT.C. Yahathugoda
Head / Senior Lecturer
Outcome results
None listed