Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

Sponsor

Indiana University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03404297

Collaborator

University of California, San Francisco (Other), Moi Teaching and Referral Hospital (Other), Moi Univeristy (Other), Purdue University (Other), Indiana Clinical and Translational Sciences Institute (Other)

250

Enrollment

Locations

Arms

27.5

Anticipated Duration (Months)

125

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Leg Ulcer Kaposi Sarcoma HIV/AIDS and Infections	Other: Locally sourced compression therapy	N/A

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

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 Design

Study Type:

Interventional

Anticipated 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.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 :

Mar 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Jun 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation) [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 [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.

Secondary Outcome Measures

Time elapsed between start of wound care and complete healing of wound (Chronic Leg Ulcer Evaluation) [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) [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) [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) [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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