Kaposi Sarcoma Clinical Trial
Official title:
Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya
Verified date | September 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Chulaimbo District Hospital | Chulaimbo | Nyanza |
Kenya | Moi Teaching and Referral Hospital | Eldoret | Uasin Gishu |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Indiana Clinical and Translational Sciences Institute, Moi Teaching and Referral Hospital, Moi Univeristy, Purdue University, University of California, San Francisco |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation) | Proportion of completely healed ulcers at 12 weeks. The unit is number of patients with an ulcer, not number of ulcers. | 3 years | |
Primary | Change in Lower Extremity Lymphedema Index (LELI) for KS | The Lower Extremity Lymphedema Index (LELI) is calculated by taking the sum of the squares of the circumference in 5 areas of a lower extremity and dividing it by the BMI. The LEL indices are significantly correlated with clinical stages and can be used as a severity scale. The LELI will compared at numerous time points throughout the study with the change in week 0 and week 14 being compared between the two arms. | 3 years | |
Secondary | Time elapsed between start of wound care and complete healing of wound (Chronic Leg Ulcer Evaluation) | This will be assessed for the observational assessment of chronic leg ulcers | 3 years | |
Secondary | Pain and itch assessment using the Numerical Rating Scale (Chronic Leg Ulcer Evaluation) | Changes in the Numerical Rating Scale will be Evaluated over the period of evaluation. This marker has been previously validated in the Kenyan setting we work in. | 3 years | |
Secondary | Ability to work (Chronic Leg Ulcer Evaluation) | The time to improvement that facilitates work will be evaluated over the course of the observational assessment | 3 years | |
Secondary | Ability to perform household tasks (Chronic Leg Ulcer Evaluation) | The time to improvement that facilitates completion of household duties will be evaluated over the course of the observational assessment | 3 years | |
Secondary | Lymphedema Quality-of-Life measure (LYMQOL) for Kaposi Sarcoma | The Lymphedema Quality-of-Life measure (LYMQOL) has separate tools for assessing arm lymphedema and leg lymphedema. This will be compared across the two arms of the study | 3 years | |
Secondary | Change in EORTC in Kaposi Sarcoma | The change in the EORTC QLQ C30 (overall health quality of life in cancer patients) will be used to compare changes from Week 0 to Week 14 between immediate intervention and delayed arm. The EORTC QLQ-C30 is a questionnaire developed by the European Organization for Research and Treatment of Cancer to assess the quality of life of cancer patients | 3 years |
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