跳至主要内容
临床试验/NCT04446767
NCT04446767已完成不适用

Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Histologic evaluation:

研究概览

简要总结

Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

详细描述

Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.

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 (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
  • •Cooperative and mentally stable patients .

排除标准

  • •Hepatic patients .
  • •Uncontrolled hypertension .
  • •Uncontrolled diabetic patients with HbA1c>8.5% .
  • •Neurological disorders .
  • •Musculoskeletal disorders that interfere with program .
  • •Previous history or any sign of DVT .

研究组 & 干预措施

Bioptron light therapy and medical care

Experimental

bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

干预措施: polarized light (Radiation)

medical care

Active Comparator

Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results

干预措施: Medical Care (Other)

结局指标

主要结局

Histologic evaluation:

时间窗: two months

Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment

Wound assessment

时间窗: two months

The wound surface area (ulcer size), lenghth and width will measured using Ruler technique

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohamed Taha

ASSISTANT PROFESSOR

Cairo University

研究点 (1)

Loading locations...

相似试验