Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wound volume
研究概览
简要总结
This study will be a randomized, open-label, pretest post-test with two study groups.
详细描述
The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive Shock wave therapy ( group A) or vacuum-assisted closure therapy (group B). Patients in both groups will receive the same medical treatment and nursing care.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.
排除标准
- •Patients with acute cellulitis, osteomyelitis, or gangrene anywhere in the affected extremity.
- •Patients with renal, hepatic, neurological, or malignant diseases.
- •Patients with severe protein malnutrition (serum albumin < 2.0 g/dl) or severe anemia (Hgb < 7.0 g/dl).
- •Patients with an ankle-brachial index < 0.7, absence of the dorsalis pedis or posterior tibial artery pulse.
- •Patients who had debridement; pregnancy.
- •Patients who refused to join the study, or to sign the written consent.
研究组 & 干预措施
Shock wave therapy group
Patients in this group were managed by shock wave therapy, using gymna Shock Master 500 with an input voltage of alternating current (AC) 220 Volte, 100 pulses at 0.13 m joule/mm at 3 Hz per session, for six weeks
干预措施: Shock wave therapy (Device)
Vacuum-assisted closure group
the patients in this group were treated by vacuum-assisted closure using KCI's Vacuum Assisted Closure Device, the pump delivered an intermittent negative pressure of -125 mmHg. The cycle was of seven minutes during which the pump was on for five minutes and off for two minutes, The dressings were changed on the fourth day.
干预措施: Vacuum-assisted closure (Device)
结局指标
主要结局
Wound volume
时间窗: change from baseline and after six weeks of intervention.
using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.
Wound surface area
时间窗: change from baseline and after six weeks of intervention.
using the ruler method to to measure the longest length and the widest width and multiplying them.
次要结局
- Wound surface area(change from baseline and after four weeks of intervention.)
- Wound volume(change from baseline and after four weeks of intervention.)
- Wound surface area(change from baseline and after two weeks of intervention.)
- Wound volume(change from baseline and after two weeks of intervention.)
研究者
Shaimaa Mohamed Ahmed Elsayeh
Lecturer of physical therapy
Cairo University