NL-OMON56830尚未招募不适用
Treatment of chronic diabetic foot ulcers with Extracorporeal Shock Wave Therapy (ESWT) - a double-blind randomized controlled trial - Shock Wave for diabetic foot ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18 years or older
- •Diabetes mellitus type I or 2
- •Uni- or bilateral chronic foot ulcers which have not healed for 6 weeks
- •Grade 1A or 2A ulcer according to the Texas Diabetic Foot Wound
- •Classification System
- •Diameter of the ulcer > 0.5 cm and < 5 cm on the plantar side of the foot
- •Ankle-brachial index > 0.7
- •Toe systolic pressure > 50 mmHg
- •Participants are mentally competent to understand and sign a Dutch informed
- •consent form themselves
排除标准
- •History of neoplasia or malignancy near the chronic diabetic foot ulcer
- •Pregnancy
- •Skeletal immaturity which has an influence on the ability to walk
- •Sign of acute local infection demanding the use of systemic antibiotics or
- •the need for amputation
- •Osteomyelitis or gangrene in the affected extremity
- •Severe anemia (Hb < 7,0g/dl)
- •Ankle brachial index < 0.7
- •Toe systolic pressure < 50 mmHg
- •Any history with ESWT
- •Two missed ESWT treatments
- •Participation in an ongoing other clinical trial
研究者
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