Defocused Shock Wave Therapy for Chronic Soft Tissue Wounds of the Lower Limbs. A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes from baseline of the wound surface
研究概览
简要总结
Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that significantly reduce the quality of life of the patient. They often do not respond to conservative treatments or advanced wound managements. Focused and defocused extracorporeal shock wave therapy can be a viable alternative therapeutic strategy.
The purpose of the study was to examine the effects of defocused extracorporeal shock wave treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound healing and pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 post-traumatic, venous, arterial, diabetic, or mixed wound of the lower limb
- •wound persisting for longer than three months
- •a wound surface bigger than 0,5 cm2
- •a wound diameter between 0.5 and 5 cm
- •unresponsiveness to conservative treatments and advanced wound managements in the 3 months prior to enrollment
- •no changes in wound managements during the study.
排除标准
- •an ankle brachial index (ABPI)<0.7 and TcPO2<40 mmHg
- •arrhythmias, presence of pacemaker, or coagulation disorders
- •use of anticoagulant drugs
- •neoplasia
- •pregnancy
- •soft tissue wound infections and/or osteomyelitis
- •patients with full-thickness loss of soft tissue and extension into muscle, bone, tendon, or joint capsule.
研究组 & 干预措施
Treatment Group
Defocused shock waves were provided by an electromagnetic generator (DUOLITH® SD1 - Storz Medical AG, Tägerwilen, Switzerland).
The protocol consisted of a series of 3 sessions in 2 weeks, 2 treatments a week. For each patient, a different number of impulses per session was delivered, depending on wound size (300 impulses + 100 impulses per cm2 wound-surface), at an energy flux density of 0.15 mJ/mm2 and a frequency of 5 pulses/s.
干预措施: Defocused shock wave therapy (DUOLITH® SD1) (Device)
结局指标
主要结局
Changes from baseline of the wound surface
时间窗: 15 days, 1 month and 3 months after treatment
Computerized digital photo documentation was used to define the size of the wound with a specific software
次要结局
- Changes from baseline of the wound characteristic(15 days, 1 month and 3 months after treatment)
- Improvement in subjective wound-related pain intensity(15 days, 1 month and 3 months after treatment)
研究者
Mario Vetrano, MD
MD
University of Roma La Sapienza