Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Detailed Description

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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 lymphedema. Chronic leg ulcers, from trauma or chronic venous disease, and lymphedema have a significant impact on quality of life, driven by pain, foul odor, and restricted mobility. The provision of compression therapy in resource-limited settings, as in western Kenya and other regions of East Africa, is a major challenge. In western Kenya, locally available elastic stockings are priced at 10-15 USD (1000-1500 kshs) per pair. Pre-packaged brand name kits are not locally available or affordable for patients, as imported kits costs 7-20 USD (700-2000 kshs) per package. However, materials used routinely in wound care, namely elastic crepe, gauze, and zinc oxide, are readily available and affordable for patients. Supplies required to dress one affected leg for a week cost 2 USD (200 kshs). The use of locally-sourced routine wound care supplies for compression therapy is poised to have significant impact on reducing morbidity, social stigma, and economic loss associated with chronic leg ulcers and Kaposi sarcoma-associated lymphedema. Demonstration of its feasibility and efficacy in treating chronic leg ulcers and Kaposi sarcoma-associated lymphedema in western Kenya could have far-reaching implications for the treatment of these prevalent conditions across East Africa and sub-Saharan Africa. This project will utilize a 1) retrospective study design to evaluate the efficacy of compression therapy for the treatment of chronic leg ulcer patients seen at Turbo Health Center, one of the Academic Model for Providing Access to Healthcare (AMPATH) sites and 2) randomized controlled trial to evaluate the efficacy of compression therapy in the management of Kaposi sarcoma leg lymphedema patients seen at AMPATH/MTRH oncology clinics. If the outcomes of this project support the use of locally-sourced compression therapy in the treatment of chronic leg ulcers and Kaposi sarcoma-associated lymphedema, future studies for chronic leg ulcers will focus on scaling up use of locally-sourced compression therapy at other AMPATH clinics and exploring feasibility of community-based care. Future studies for Kaposi sarcoma lymphedema will focus on exploring feasibility of community or home-based lymphedema care.

Conditions

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Chronic Leg Ulcer Kaposi Sarcoma HIV/AIDS and Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The trial is open label but the randomization scheme will be determined by an automatic randomization algorithm performed independently of the investigators

Study Groups

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Immediate Compression Therapy Arm

Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy

Group Type EXPERIMENTAL

Locally sourced compression therapy

Intervention Type OTHER

The dressing is made up of a zinc oxide impregnated compression wrapping

Delayed Compression Therapy Arm

Patients in this arm will receive a locally sourced version of compression therapy after completing \~ 14 weeks of chemotherapy.

Group Type PLACEBO_COMPARATOR

Locally sourced compression therapy

Intervention Type OTHER

The dressing is made up of a zinc oxide impregnated compression wrapping

Interventions

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Locally sourced compression therapy

The dressing is made up of a zinc oxide impregnated compression wrapping

Intervention Type OTHER

Eligibility Criteria

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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

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No