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临床试验/NCT06670417
NCT06670417尚未招募不适用

Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
wound surface area

研究概览

简要总结

The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ?

After clinical assessment patients will be randomly allocated into three groups equal in number:

Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week).

Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).

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
None

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index of 25-34.9 kg/m
  • Glycated hemoglobin (HbA1c) >7 %.
  • ABP index absolute normal (1-1.3)
  • Patient with polyneuropathy.
  • Patient suffer from diabetes more than 5 years.
  • Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.

排除标准

  • Patients with history of hypo- hyperglycemic coma.
  • Uncontrolled cardiovascular complications.
  • Malignancy, Anemia, Hemorrhagic diseases.
  • Cardiac peace maker.
  • Deep venous thrombosis.
  • Osteomyelitis.
  • Patients with Monckeberg sclerosis.
  • Photosensitivity to laser.

研究组 & 干预措施

B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with

Experimental

干预措施: Buerger Allen exercise (Other)

(C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua

Experimental

干预措施: Regular wound care (Other)

结局指标

主要结局

wound surface area

时间窗: From enrollment to the end of treatment at 2 weeks

Glycated hemoglobin HbA1c

时间窗: From enrollment to the end of treatment at 12weeks

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

Heba afifi

lecturer Assistant

Cairo University

研究点 (1)

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