NCT04716790Unknown不适用
Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Healing Rate
研究概览
简要总结
The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.
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
- Single (Investigator)
盲法说明
The clinician who performs the cures, photographs and data collection is different from the clinician who performs the application of ultrasound debridement. Therefore, the evaluator will be blinded.
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
- •Male and female patients ≥18 years old.
- •Type 1 or type 2 diabetes mellitus with HbA1c ≤ 10%.
- •DFU grades IA, IIA, IB, IIB, IC, IIC, ID, IID, according to the University of Texas Classification.
- •DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderate infection, according to the PEDIS-IDSA Classification.
- •Wound size between 1 cm² and 30 cm².
- •Evolution time DFU between 1 and 24 months.
- •Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7
排除标准
- •Critical limb ischemia patients with ABI≤0.5 and ASBP<70mmHg or TSBP<50mmHg.
- •Clinical suspicion of osteomyelitis.
- •Pregnant or lactating women or women of childbearing potential who are not using effective contraception.
- •Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)
结局指标
主要结局
Healing Rate
时间窗: 12 weeks
Total epithelialization of the wound.
Healing Time
时间窗: 12 weeks
Time from the inclusion of the wound in the study until its total epithelialization.
Wound Size
时间窗: 12 weeks
Planimetric measurements of wound size will be made using Visitrak (Smith \& Nephew, Hull, UK).
次要结局
- Transcutaneous oxygen pressure (TcPO2)(baseline and week 7)
- Health-related quality of life(baseline and 12 week)
- Wound Conditions(12 weeks)
- Pain intensity(12 weeks)
研究者
Sebastian Flores Escobar
Principal Investigator
Universidad Complutense de Madrid
研究点 (2)
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