An interventional study of Locally sourced compression therapy in Chronic Leg Ulcer, Kaposi Sarcoma and HIV/AIDS and Infections, sponsored by Indiana University. Completed at 2 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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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
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.
161 studies on the registry are indexed under Sarcoma, Kaposi; 24 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 114 interventional studies indexed under Sarcoma, Kaposi.
Browse Sarcoma, Kaposi studies →Indiana University is the lead sponsor of 988 studies on the registry; 200 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Retrospective Chronic Leg Ulcer Arm Investigation
Inclusion Criteria:
Exclusion Criteria:
Prospective Kaposi Sarcoma Investigation
Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy
Other: Locally sourced compression therapy
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
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.
Time frame: 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.
Time frame: 3 years
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 years
Plan to share: No — We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information.
Ran from Mar 2018 to primary completion in Dec 2019, 21 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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