Effects of High Voltage Pulsed Current and Low Level Laser Therapy on Wound Healing in Diabetic Ulcers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Neuroconduction studies with the Nicolet Compass Meridian equipment.
研究概览
简要总结
The purpose of this study was to compare the effects of high voltage pulsed current and low level laser therapy on the healing process of diabetic foot ulcers.
详细描述
Based in the literature review we concluded that LLLT and HVPC are effective in the healing wound. We did not meet outcomes of previous clinical studies, where compare the effectivity of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation risk and the consequent impairment and dysfunction in the quality of life, and the associated high costs for this health problem, it is important that new studies that identified effective treatment alternatives for promoting wound closure.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 30 - 75 years
- •Ulcer located on the legs or feet, stage I or II (Wagner Classification System)
- •Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, two random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)
排除标准
- •Uncontrolled diabetes
- •Ulcer infection
- •Lower limb amputation
- •Orthopedic or neuromuscular pathologic conditions
结局指标
主要结局
Neuroconduction studies with the Nicolet Compass Meridian equipment.
时间窗: The neuroconduction was performed at the beginning and end of the treatment and 60 days thereafter.
Characteristics of the wound
时间窗: The wounds were evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention
Sensory testing with the Semmes-Weinstein monofilament
时间窗: The monofilament testing was performed at the beginning and end of the treatment and 60 days thereafter.
Quality of life with the EQ-5D.
时间窗: The quality of life was applied at the begining and at the end of the treatment.
Ankle Brachial Index (ABI)
时间窗: The Ankle Braquial Index (ABI) was evaluated at the beginning of the study (debridement previous), each two weeks during the intervention, at the finish of treatment and 30 and 60 days after completion of the intervention.
次要结局
- Sociodemographic data like gender and age, were recorded. Additionally clinical history, deformities, alcohol dependence or smoking history, previous and present pharmacologic treatment and corticosteroids were included.(These outcome measures were assessed in the initial examination.)