Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
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ClinicalTrials.gov Identifier: NCT03404297 |
Recruitment Status : Unknown
Verified January 2018 by Indiana University.
Recruitment status was: Recruiting
First Posted : January 19, 2018
Last Update Posted : April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic Leg Ulcer Kaposi Sarcoma HIV/AIDS and Infections | Other: Locally sourced compression therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The study will include two different types of evaluation based on the disease process that the patient has. For patients with chronic leg ulcers, a retrospective, observational approach will be used to track the efficacy of locally sourced compression in improving wound healing. For patients with Kaposi Sarcoma associated leg lymphedema, they will be randomized to to receive immediate compression therapy or delayed compression therapy. |
Masking: | None (Open Label) |
Masking Description: | The trial is open label but the randomization scheme will be determined by an automatic randomization algorithm performed independently of the investigators |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya |
Actual Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | December 31, 2019 |
Estimated Study Completion Date : | June 15, 2020 |

Arm | Intervention/treatment |
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Experimental: Immediate Compression Therapy Arm
Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy
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Other: Locally sourced compression therapy
The dressing is made up of a zinc oxide impregnated compression wrapping |
Placebo Comparator: Delayed Compression Therapy Arm
Patients in this arm will receive a locally sourced version of compression therapy after completing ~ 14 weeks of chemotherapy.
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Other: Locally sourced compression therapy
The dressing is made up of a zinc oxide impregnated compression wrapping |
- Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation) [ Time Frame: 3 years ]Proportion of completely healed ulcers at 12 weeks. The unit is number of patients with an ulcer, not number of ulcers.
- Change in Lower Extremity Lymphedema Index (LELI) for KS [ Time Frame: 3 years ]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.
- Time elapsed between start of wound care and complete healing of wound (Chronic Leg Ulcer Evaluation) [ Time Frame: 3 years ]This will be assessed for the observational assessment of chronic leg ulcers
- Pain and itch assessment using the Numerical Rating Scale (Chronic Leg Ulcer Evaluation) [ Time Frame: 3 years ]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.
- Ability to work (Chronic Leg Ulcer Evaluation) [ Time Frame: 3 years ]The time to improvement that facilitates work will be evaluated over the course of the observational assessment
- Ability to perform household tasks (Chronic Leg Ulcer Evaluation) [ Time Frame: 3 years ]The time to improvement that facilitates completion of household duties will be evaluated over the course of the observational assessment
- Lymphedema Quality-of-Life measure (LYMQOL) for Kaposi Sarcoma [ Time Frame: 3 years ]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
- Change in EORTC in Kaposi Sarcoma [ Time Frame: 3 years ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404297
Contact: Sonak D Pastakia, PharmD,PhD | 2155949414 | spastaki@gmail.com | |
Contact: Rakhi Karwa, PharmD | +1 (415) 572-3621 | rakhikarwa@gmail.com |
Kenya | |
Chulaimbo District Hospital | Recruiting |
Chulaimbo, Nyanza, Kenya | |
Contact: Edith Chepngeno, BPharm edithtonui@gmail.com | |
Moi Teaching and Referral Hospital | Recruiting |
Eldoret, Uasin Gishu, Kenya, 30100 | |
Contact: Sonak Pastakia spastaki@gmail.com |
Principal Investigator: | Sonak D Pastakia, PharmD,PhD | Purdue University |
Responsible Party: | Indiana University |
ClinicalTrials.gov Identifier: | NCT03404297 |
Other Study ID Numbers: |
1710769547 |
First Posted: | January 19, 2018 Key Record Dates |
Last Update Posted: | April 12, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
compression therapy Kenya Kaposi Sarcoma |
Locally sourced wrapping chronic leg ulcers |
Sarcoma, Kaposi Sarcoma Leg Ulcer Skin Ulcer Ulcer Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Pathologic Processes Infections Virus Diseases Skin Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue |