Chronic Leg UlcerNCT03404297
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
A study testing Locally sourced compression therapy in people with Chronic Leg Ulcer and Kaposi Sarcoma, run by Indiana University at 2 sites in Kenya.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leg Ulcer, Kaposi Sarcoma, HIV/AIDS and Infections
- What is being tested?
- Locally sourced compression therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesKenya
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Older than 18 years of age
- Diagnosis of biopsy-proven Kaposi sarcoma with associated leg lymphedema
Show all 12Show fewer
- 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
Who cannot join
- 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
- HIV negative
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Chulaimbo District Hospital
Chulaimbo, Nyanza
Moi Teaching and Referral Hospital
Eldoret, Uasin Gishu County, 30100
About this study
Official title: 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
Read the 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.
- Conditions
- Chronic Leg Ulcer, Kaposi Sarcoma, HIV/AIDS and Infections
- Being tested
- Locally sourced compression therapy
- Keywords
- compression therapy, Kenya, Kaposi Sarcoma, Locally sourced, wrapping, chronic leg ulcers
- Medical subject headings
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locally sourced compression therapyOther
The dressing is made up of a zinc oxide impregnated compression wrapping
| Study group | Role | What they receive |
|---|---|---|
| Immediate Compression Therapy Arm | Experimental | Patients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy Receives: 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. Receives: Other: Locally sourced compression therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Leg UlcerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Moi Teaching and Referral Hospital, Moi Univeristy, Purdue University, Indiana Clinical and Translational Sciences Institute
- Responsible party
- Principal investigator, Sonak Pastakia, Indiana University
- Investigators
- Sonak D Pastakia, PharmD,PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404297
- Sponsor's protocol ID
- 1710769547
- Status last verified
- Sep 2023
- First submitted
- 12 Jan 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information.
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.
PubMed 35025687Chang 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.
PubMed 30402565
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya
- ClinicalTrials.gov ID
- NCT03404297
- Acronym / sponsor ID
- 1710769547
- Conditions
- Chronic Leg Ulcer, Kaposi Sarcoma, HIV/AIDS and Infections
- Keywords
- compression therapy, Kenya, Kaposi Sarcoma, Locally sourced, wrapping, chronic leg ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Moi Teaching and Referral Hospital, Moi Univeristy, Purdue University, Indiana Clinical and Translational Sciences Institute
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Compression Therapy Arm | Experimental | Other: Locally sourced compression therapyPatients in this arm will receive a locally sourced version of compression therapy while concurrently receiving chemotherapy |
| Delayed Compression Therapy Arm | Placebo comparator | Other: Locally sourced compression therapyPatients in this arm will receive a locally sourced version of compression therapy after completing ~ 14 weeks of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Older than 18 years of age
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locally sourced compression therapyThe dressing is made up of a zinc oxide impregnated compression wrapping | Other | Delayed Compression Therapy Arm, Immediate Compression Therapy Arm |
Primary outcome
Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Time elapsed between start of wound care and complete healing of wound (Chronic Leg Ulcer Evaluation)
Time frame: 3 years
Pain and itch assessment using the Numerical Rating Scale (Chronic Leg Ulcer Evaluation)
Time frame: 3 years
Ability to work (Chronic Leg Ulcer Evaluation)
Time frame: 3 years
Ability to perform household tasks (Chronic Leg Ulcer Evaluation)
Time frame: 3 years
Lymphedema Quality-of-Life measure (LYMQOL) for Kaposi Sarcoma
Time frame: 3 years
Change in EORTC in Kaposi Sarcoma
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 35025687Chang 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.
- Derived from this study: PubMed 30402565Chang 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.
- Individual participant dataSharing planned: No. We don't intend to share this information unless there is a compelling, patient centered reason for sharing this information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonak D Pastakia, PharmD,PhD principal investigator
Purdue University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locally sourced compression therapy in people with Chronic Leg Ulcer and Kaposi Sarcoma, run by Indiana University at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.