Clinical trial · Interventional
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya
NCT03404297CI-TRIAL-00069997completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The efficacy of locally sourced compression therapy in the management of chronic leg ulcers and Kaposi Sarcoma in western Kenya will be studied in a rural setting
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Leg Ulcer | — | UNRESOLVED | — |
| HIV/AIDS and Infections | — | UNRESOLVED | — |
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Locally sourced compression therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate Compression Therapy Arm
- description
- Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy
- interventionNames
- Other: Locally sourced compression therapy
- type
- PLACEBO_COMPARATOR
- label
- Delayed Compression Therapy Arm
- description
- Patients in this arm will receive a locally sourced version of compression therapy after completing \~ 14 weeks of chemotherapy.
- interventionNames
- Other: Locally sourced compression therapy
Primary outcomes (2)
- measure
- Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Retrospective Chronic Leg Ulcer Arm Investigation Inclusion Criteria: * Older than 18 years of age * Received paste bandage compression therapy as part of routine wound care * Presence of venous ulcer for more than 6 weeks. Venous ulcer defined as a wound of the lower extremity in an individual with adequate lower extremity arterial flow located in the gaiter region of the leg (between the knee and ankle) with clinical signs of venous disease (edema, varicose veins) (19) OR * Presence of trauma-related ulcer for more than 6 weeks Exclusion Criteria: * Patients with peripheral arterial disease as documented via documented history or peripheral vascular physical examination. (20) * Patients diagnosed with diabetic foot ulcers * Patients diagnosed with ulcers from inflammatory conditions (pyoderma gangrenosum, vasculitis, rheumatoid arthritis, and other connective tissue diseases/autoimmune diseases) * Concomitant diagnosis of decompensated heart failure, acute phase dermatitis (at the time of the study), acute phase deep vein thrombosis Prospective Kaposi Sarcoma Investigation Inclusion Criteria: * Older than 18 years of age * Diagnosis of biopsy-proven Kaposi sarcoma with associated leg lymphedema * Leg lymphedema consistent with Campisi Clinical Stage 1B, 2, 3, 4 (Table 4). At these stages, lymphedema is clinically evident and not yet permanently fibrotic, sclerotic, or indurated with verrucous change. * HIV positive * On highly active anti-retroviral therapy * About to initiate a course of chemotherapy * Willingness to participate for the entire study duration, ranging from at least 14 weeks and up to 24 weeks, depending on randomization. * Provision of written Informed Consent Exclusion Criteria * HIV negative * Leg lymphedema consistent with Campisi Clinical Stage 1A or 5 (Table 4). At these stages, lymphatic dysfunction is not yet clinically evident (Stage 1A) or lymphedema has become permanently fibrotic, sclerotic, or indurated with verrucous change (Stage 5). * History of another cancer diagnosis * Concomitant peripheral arterial disease as documented via history or peripheral vascular physical examination * Concomitant diagnosis of decompensated heart failure, acute phase dermatitis (at the time of the study), rheumatoid arthritis, acute phase deep vein thrombosis * Diagnosis of medical conditions that may also lead to lower extremity lymphedema, including: congestive heart failure, filiariasis, previous vein stripping or peripheral vascular surgery * Current use of medications known to cause edema, (i.e. calcium channel blockers, systemic corticosteroids) * Pregnant
References
Publications (2)
- DERIVEDChang AY, Karwa R, Odhiambo H, Were P, Fletcher SL, Tonui EC, Kohn MA, Lee J, Chang D, Lensing S, Namaemba DF, Busakhala N, Kiprono SK, Maurer T, Goodrich S, Pastakia SD. Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial. JCO Glob Oncol. 2022 Jan;8:e2100329. doi: 10.1200/GO.21.00329. PMID 35025687
- DERIVEDChang AY, Karwa R, Busakhala N, Fletcher SL, Tonui EC, Wasike P, Kohn MA, Asirwa FC, Kiprono SK, Maurer T, Goodrich S, Pastakia SD. Randomized controlled trial to evaluate locally sourced two-component compression bandages for HIV-associated Kaposi sarcoma leg lymphedema in western Kenya: The Kenyan Improvised Compression for Kaposi Sarcoma (KICKS) study protocol. Contemp Clin Trials Commun. 2018 Oct 21;12:116-122. doi: 10.1016/j.conctc.2018.10.003. eCollection 2018 Dec. PMID 30402565