NCT05739149招募中不适用
Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Microvessel imaging
研究概览
简要总结
The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
- •Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management.
- •For chronic venous ulcers, ultrasound demonstrates venous reflux >0.5 seconds
- •Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c <6.5%
- •Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 > 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
- •In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by ultrasound.
- •Ankle-brachial index (ABI) ≥ 0.8
排除标准
- •Acute wound with duration less than 6 weeks
- •Evidence of active infection or on antibiotics
- •For chronic venous ulcers, ultrasound demonstrates venous reflux <0.5 seconds
- •Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c <6.5%
- •Poor blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 < 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
- •Ankle-brachial index (ABI) <
- •Pregnancy
- •Known allergy to lidocaine
结局指标
主要结局
Microvessel imaging
时间窗: 3 months
Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing
次要结局
未报告次要终点
研究者
Michael R. Moynagh
Principal Investigator
Mayo Clinic
研究点 (2)
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