Evaluation of Locally-sourced Compression Therapy for Treatment of Chronic Leg Ulcers and Management of Kaposi Sarcoma Leg Lymphedema in Western Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in Lower Extremity Lymphedema Index (LELI) for KS
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The trial is open label but the randomization scheme will be determined by an automatic randomization algorithm performed independently of the investigators
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in Lower Extremity Lymphedema Index (LELI) for KS
时间窗: 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.
Complete Resolution of ulcers (Chronic Leg Ulcer Evaluation)
时间窗: 3 years
Proportion of completely healed ulcers at 12 weeks. The unit is number of patients with an ulcer, not number of ulcers.
次要结局
- Pain and itch assessment using the Numerical Rating Scale (Chronic Leg Ulcer Evaluation)(3 years)
- Ability to work (Chronic Leg Ulcer Evaluation)(3 years)
- Time elapsed between start of wound care and complete healing of wound (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)
- Change in EORTC in Kaposi Sarcoma(3 years)
研究者
Sonak Pastakia
Professor of Pharmacy
Indiana University