A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Transcutaneous Oxygen Pressure (TcPO2)
研究概览
简要总结
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
详细描述
The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with PAD and DFU. Each subject will receive one 90-minute TUS treatment in each of 3 treatment sessions. All post-treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Though the treatment device will be known to all participants, the level of treatment will be randomized among 3 distinct sessions and the level of treatment will be masked for the subject (participant), care provider, investigator, and outcomes assessor.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one DFU (grade 0 or 1 by University of Texas classification)
- •Diagnosis of diabetes mellitus
- •Diagnosis of PAD that meets at least one of the following conditions:
- •Ankle-brachial index (ABI) of < 0.9 in the same limb as the DFU
- •Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg
- •Documented history of PAD for a minimum of 3 calendar months prior to time of enrollment
- •Aged ≥ 22 years
排除标准
- •Rutherford 6 stage PAD
- •Active DFU infection
- •End-stage renal disease on dialysis
- •HbA1c > 13%.
- •Planned PAD revascularization.
- •Prior stenting in posterior tibial artery.
- •Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet all other criteria).
- •History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
- •Acute limb ischemia within 30 days prior to treatment.
- •History or diagnosis of deep venous thrombosis below the knee in treatment leg.
- •Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
- •Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
结局指标
主要结局
Transcutaneous Oxygen Pressure (TcPO2)
时间窗: Through study completion, an average of 1 month.
noninvasive test that directly measures the oxygen level of tissue beneath the skin
次要结局
- Percent Change From Baseline in Perfusion Rate of the Targeted Foot(Through study completion, an average of 1 month)
- Tissue Oxygen Saturation (StO2)(Through study completion, an average of 1 month)
- Ankle Brachial Index (ABI)(Through study completion, an average of 1 month)