Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya

NCT03404297 | Completed

• 1 other identifier: 1710769547
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

compression therapy; Kenya; Kaposi Sarcoma; Locally sourced; wrapping; chronic leg ulcers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

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

  3 years

• Pain and itch assessment using the Numerical Rating Scale (Chronic Leg Ulcer Evaluation)

  3 years

• Ability to work (Chronic Leg Ulcer Evaluation)

  3 years

• Ability to perform household tasks (Chronic Leg Ulcer Evaluation)

  3 years

• Lymphedema Quality-of-Life measure (LYMQOL) for Kaposi Sarcoma

  3 years

Study Arms (2)

Immediate Compression Therapy Arm

EXPERIMENTAL

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

Other: Locally sourced compression therapy

Delayed Compression Therapy Arm

PLACEBO COMPARATOR

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

Other: Locally sourced compression therapy

Interventions

Locally sourced compression therapy OTHER

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

Delayed Compression Therapy Arm; Immediate Compression Therapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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).

Sponsors & Collaborators

• Indiana University: lead
• University of California, San Francisco: collaborator
• Moi Teaching and Referral Hospital: collaborator
• Moi Univeristy: collaborator
• Purdue University: collaborator
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (2)

Chulaimbo District Hospital

Chulaimbo, Nyanza, Kenya

Location

Moi Teaching and Referral Hospital

Eldoret, Uasin Gishu County, 30100, Kenya

Location

Related Publications (2)

• 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.

  PMID: 35025687 DERIVED

• 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.

  PMID: 30402565 DERIVED

MeSH Terms

Conditions

Sarcoma, Kaposi; Acquired Immunodeficiency Syndrome; Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sonak D Pastakia, PharmD,PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial is open label but the randomization scheme will be determined by an automatic randomization algorithm performed independently of the investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacy

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)