Impaired Wound Healing in Diabetic Foot Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
研究概览
简要总结
An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.
详细描述
An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis of Type I or Type II Diabetes Mellitus.
- •Ulcer present for minimum 4 weeks
- •Have adequate circulation to the foot
- •Can return for follow-up visits
- •Be able to read and sign the Informed Consent form before enrollment
排除标准
- •Active Charcot's foot ulcer on the foot to be studied
- •Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
- •Alcohol or drug abuse problems
- •Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- •Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
- •Pregnancy
研究者
Aristidis Veves
Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics
Beth Israel Deaconess Medical Center