Status:
COMPLETED
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
Lead Sponsor:
Indiana University
Collaborating Sponsors:
University of California, San Francisco
Moi Teaching and Referral Hospital
Conditions:
Chronic Leg Ulcer
Kaposi Sarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Detailed Description
Compression therapy is a well-established cornerstone therapy and part of routine clinical care for chronic leg ulcers from venous disease and lymphedema, including Kaposi sarcoma (KS)-associated lymp...
Eligibility Criteria
Inclusion
- Retrospective Chronic Leg Ulcer Arm Investigation
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03404297
Start Date
March 1 2018
End Date
December 31 2019
Last Update
September 28 2023
Active Locations (2)
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1
Chulaimbo District Hospital
Chulaimbo, Nyanza, Kenya
2
Moi Teaching and Referral Hospital
Eldoret, Uasin Gishu County, Kenya, 30100