Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in the Genetic Profile After Debridement in the Intervention Group.
研究概览
简要总结
The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •>18 years of age
- •Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)
- •have a venous ulcer between the knee and ankle, at or above the malleolus
- •wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone
- •wound duration of at least 6 months
- •VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue
- •ability of subject to tolerate limb compression bandage
排除标准
- •history of diabetes mellitus and a HbA1c > 12% (obtained within past 6 months)
- •Ankle brachial index(ABI) less than 0.80
- •any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
- •suspicion of malignancy within VLU
- •life expectancy <6 months
- •history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
- •history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) >2x upper limit of normal (obtained within past 6 months)
- •requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
- •history of immunodeficiency
- •ulcers due to none venous etiology and leg ulcers associated with mixed etiology
- •Untreated osteomyelitis
- •acute deep venous thrombosis
- •allergy to lidocaine and/or epinephrine
- •Subject's inability to successfully tolerate compression therapy that is changed weekly
- •Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
- •if currently incarcerated
- •known pregnancy
研究组 & 干预措施
Wound Edge Debridement Group
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
干预措施: Wound Edge Debridement (Procedure)
Wound Edge Debridement Group
Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
干预措施: Standard of Care Treatment (Other)
Standard care group
Participants in this group will receive only the standard care of treatment for up to 4 weeks.
干预措施: Standard of Care Treatment (Other)
结局指标
主要结局
Change in the Genetic Profile After Debridement in the Intervention Group.
时间窗: Baseline and 4 weeks
RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.
次要结局
- Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group(Baseline to 4 weeks)
研究者
Robert S. Kirsner
Professor & Chairman
University of Miami