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临床试验/NCT03338517
NCT03338517已完成不适用

A Randomized Controlled Trial Comparing Helium-Neon Laser Therapy and Infrared Laser Therapy in Patients With Diabetic Foot Ulcer

Ahlia University0 个研究点目标入组 65 人开始时间: 2016年8月4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
65
主要终点
Ulcer surface area

研究概览

简要总结

Background: Diabetic patients are frequently showed with foot ulceration as a common complication which increases to 20% in admission. Low-level laser therapy is used to control foot ulcer, but there is very limited data to compare the effects of Helium-Neon Laser therapy (HNLT) and Infrared Laser therapy (ILT) on diabetic foot ulcer.

Objectives: This study aimed to compare the effects of (HNLT) and (ILT) on diabetic foot ulcer.

Methods: Sixty-five patients with diabetic foot ulcer (51 males and 14 females) aged 50-60years. The participants were classified randomly to two groups, Helium-Neon Laser therapy (HNLT) and Infrared Laser therapy (ILT) groups. HNLT group received medical treatment with Helium-Neon Laser therapy and ILT group received medical treatment with Infrared Laser therapy for 8 weeks. Ulcer surface area was assessed using a sheet of cellophane paper at the beginning of the study, after four weeks, and after eight weeks at the end of the study.

详细描述

The study was carried out after obtaining ethical approval from the Department of surgery, Cairo University Hospitals, Egypt. Patients with varying stages of diabetic foot ulcers in the hospital were screened and included in the study. 65 diabetic patients with Grade I and II ulcers were selected according to Wagner classification, ages ranged between 50 to 60 years of age, BMI of 30 free from any metabolic-related medical conditions such as nephropathy, cardiomyopathy, recent myocardial infarction and pulmonary problems. Patients were randomized into two groups; Group (I) who received medical treatment with Helium-Neon Laser therapy (HNLT), (ASA Medical laser device (manufactured by ASA Terza- Via Alessandro, Italy) and Group (II) who received medical treatment with Infrared Laser therapy (ILT), (PHYACTION 792/796 manufactured in The Netherlands by Uniphy BV). The nature of the therapy was described and explained to the patient. A written informed consent was obtained prior to implementation of the study. Patients were subjected to detailed medical examination. Glucosylated Homoglobin (HbA1c) was obtained for patient screening.

Outcome measures Ulcer surface area was calculated by getting the impression of the ulcer floor using a sheet of cellophane paper. The imprint of the ulcer floor is transferred to graphing paper where ulcer size was plotted and diameter was recorded. Ulcer size was measured at the beginning of the study, after 4 weeks, and after 8 weeks at the end of study.

The position of patient was a comfortable position with disclosure of the affected foot. Transparent plastic films were double sterilized and directly placed flat and connected to the skin at the ulcer area with nullifing any motion or misrepresentation of the affected foot. The margins of the ulcer were followed by the same investigator to set up the measurements reliability16.

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
Double (Participant, Outcomes Assessor)

盲法说明

Group (I) who received medical treatment with Helium-Neon Laser therapy (HNLT), (ASA Medical laser device (manufactured by ASA Terza- Via Alessandro, Italy) and Group (II) who received medical treatment with Infrared Laser therapy (ILT), (PHYACTION 792/796 manufactured in The Netherlands by Uniphy BV). The nature of the therapy was described and explained to the patient.

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with Grade I and II ulcers were selected according to Wagner classification ages ranged between 50 to 60 years of age, BMI of 30

排除标准

  • •nephropathy, cardiomyopathy, recent myocardial infarction and pulmonary problems

研究组 & 干预措施

Study group

Active Comparator

Helium Neon Laser

干预措施: Helium Neon Laser (Other)

Control group

No Intervention

No intervention

结局指标

主要结局

Ulcer surface area

时间窗: 6 months

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

Dr Sayed Tantawy

Associate Professor

Ahlia University

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