跳至主要内容
临床试验/CTRI/2024/05/066944
CTRI/2024/05/066944尚未招募3 期

Chronic non-healing diabetic foot ulcer-RCT study-using near infra-red laser and conventional saline dressing

Dr Sivaguru1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To compare the improvement of wound in chronic non healing diabetic foot ulcer using near infra red laser and conventional saline dressing

研究概览

简要总结

Chronic wound is defined as one that fails to heal in the expected time for a wound of that type, which is usually less than 3 weeks. The number of patients with chronic non healing wound are likely to increase as a result of an ageing population and raising incidence of risk factors for atherosclerotic disease such as diabetes and smoking. Diabetes is a complex metabolic disease where lower limb wound are more prevalant. Foot ulceration is the major problem commonly encountered in patients with diabetes mellitus, The factors implicated being a triad of arterial disease, neuropathy, infection. The ulcers result in a chronic wound, which is resistant to treatment and may lead to catastrophic sequele. Wound dressing has been the mainstay, but it requires compliance from the patient for a long period. Many forms of adjuvant treatment have been tried to speed up the healing process of diabetic foot ulcer. One of these mode of treatment is near infra red laser therapy (NIR). It will penetrate deep into tissued and are applied to treat deep seated tissues. Lights in this specific range reach direct target in the cell causing an increase in the photon on the wound surface and speeding up the rate of wound healing. The absorbed laser energy stimulates molecules and atom of cells but does not cause rapid or significant increase in tissue temperature. The aim of this randomized control study is to understand and predict the reduction in wound surface area by exposing to infra red laser application in chronic non healing diabetic foot ulcer

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.patients with chronic non healing diabetic foot ulcer (more than 3 weeks) 2.Depth ischaemia classification- grade I foot ulcer 3.the patient who understood the compliance as they were required to undergo the respective treatment for two weeks.

排除标准

  • Patient with any associated co-morbidities like PVD
  • Patient with deep ulcers with exposed tendons and bone
  • patient with uncontrolled glycemic index.

结局指标

主要结局

To compare the improvement of wound in chronic non healing diabetic foot ulcer using near infra red laser and conventional saline dressing

时间窗: 2 weeks

次要结局

  • to understand and predict the reduction in wound surface area by exposing to infra red laser application in chronic non healing diabetic foot ulcers(2 weeks)

研究者

发起方
Dr Sivaguru
申办方类型
Other [myself]
责任方
Principal Investigator
主要研究者

Dr Sivaguru

Sri manakula vinayagar medical college and hospital

研究点 (1)

Loading locations...

相似试验