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

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

Study Overview

• Status: Completed
• Conditions: Kaposi Sarcoma; HIV/AIDS and Infections; Chronic Leg Ulcer
• Intervention / Treatment: Other: Locally sourced compression therapy

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Chulaimbo, Nyanza, Kenya
      • Chulaimbo District Hospital
  • Uasin Gishu
    • Eldoret, Uasin Gishu, Kenya, 30100
      • Moi Teaching and Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Compression Therapy Arm; Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy	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.	Other: Locally sourced compression therapy; The dressing is made up of a zinc oxide impregnated compression wrapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: University of California, San Francisco; Indiana Clinical and Translational Sciences Institute; Purdue University; Moi Univeristy; Moi Teaching and Referral Hospital
• Investigators: Principal Investigator: Sonak D Pastakia, PharmD,PhD, Purdue University

Publications and helpful links

General Publications

• Chang 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.
• Chang 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Kenya; compression therapy; Kaposi Sarcoma; Locally sourced; wrapping; chronic leg ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; DNA Virus Infections; Herpesviridae Infections; Neoplasms, Vascular Tissue; Sarcoma; Ulcer; Leg Ulcer; Sarcoma, Kaposi; Skin Ulcer
• Other Study ID Numbers: 1710769547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No