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Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

Primary Purpose

Chronic Leg Ulcer, Kaposi Sarcoma, HIV/AIDS and Infections

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Locally sourced compression therapy
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Leg Ulcer focused on measuring compression therapy, Kenya, Kaposi Sarcoma, Locally sourced, wrapping, chronic leg ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chulaimbo District Hospital
  • Moi Teaching and Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Immediate Compression Therapy Arm

Delayed Compression Therapy Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
Ability to work (Chronic Leg Ulcer Evaluation)
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)
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
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
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

Full Information

First Posted
January 12, 2018
Last Updated
September 26, 2023
Sponsor
Indiana University
Collaborators
University of California, San Francisco, Moi Teaching and Referral Hospital, Moi Univeristy, Purdue University, Indiana Clinical and Translational Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03404297
Brief Title
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
Official Title
Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
University of California, San Francisco, Moi Teaching and Referral Hospital, Moi Univeristy, Purdue University, Indiana Clinical and Translational Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Leg Ulcer, Kaposi Sarcoma, HIV/AIDS and Infections
Keywords
compression therapy, Kenya, Kaposi Sarcoma, Locally sourced, wrapping, chronic leg ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonak D Pastakia, PharmD,PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulaimbo District Hospital
City
Chulaimbo
State/Province
Nyanza
Country
Kenya
Facility Name
Moi Teaching and Referral Hospital
City
Eldoret
State/Province
Uasin Gishu
ZIP/Postal Code
30100
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information.
Citations:
PubMed Identifier
35025687
Citation
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.
Results Reference
derived
PubMed Identifier
30402565
Citation
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.
Results Reference
derived

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Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

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