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临床试验/NCT06756386
NCT06756386尚未招募不适用

Effect of Extra Corporeal Shock Wave Versus Low Level Laser on Chronic Venous Ulcer Healing

Beni-Suef University0 个研究点目标入组 45 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
ulcer size

研究概览

简要总结

To find out the difference in the effect of shock wave therapy and low level laser therapy on venous ulcer patient As regards the following outcomes;

  1. medical state of patient no ( diabetes, hypertension,obesity,cancer , rheumatoid)
  2. The degree of ulcer
  3. recurrence of ulcer
  4. The degree of pain and disabilities
  5. inflammatory marker

详细描述

45 venous ulcer patient of both sexes will be recruited in this study from cardiovascular units in nasser institute hospital , their age ranged from 45 to 60 years old and randomly divided into 3 equal groups

  1. study group (A) include old age patients with venous ulcer will receive extra corporeal shock wave therapy along with conservative treatment (compression therapy (pressure garment),lifestyle changes, physical activity) plus medical treatment
  2. study group (B) include old age patient with chronic venous ulcer will receive low level laser therapy along with conservative treatment (compression therapy (pressure garment), lifestyle changes,physical activity) Plus medical treatment
  3. control group (C) include old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment The study will be conducted when the patient stable medically and will be conducted until complete healing of ulcer

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All old age patients will be
  • •Ranging from 45-60 years old
  • •With BMI from (25-30)
  • •Chronic venous ulcer grade 2 or 3
  • •Ulcers non infected with superficial blood insufficiency
  • •open ulcers.

排除标准

  • •-Diabetes
  • •hypertension
  • •rheumatoid arthritis
  • •Musculoskeletal disorders
  • •cerbrovascular stroke
  • •Deep venous thrombosis
  • •deep venous ulcer
  • •venous ulcer grade 4

研究组 & 干预措施

group A

Active Comparator

study group (A) include 15 old age patients with venous ulcer will receive extra corporeal shock wave therapy along with conservative treatment (compression therapy (pressure garment),lifestyle changes, physical activity) plus medical treatment

干预措施: extra corporeal shock wave therapy (ESWT ) (Device)

Group B

Active Comparator

study group (B) include 15 old age patient with chronic venous ulcer will receive low level laser therapy along with conservative treatment (compression therapy (pressure garment), lifestyle changes,physical activity) Plus medical treatment

干预措施: Low Level Laser Therapy (Device)

Group C

Active Comparator

control group (C) include 15 old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment

干预措施: conservative treatments (Other)

结局指标

主要结局

ulcer size

时间窗: 4 weeks

Smart phone application imito wound application was found to be reliable for three-dimensional analysis such as depths and volumes, its results were less suited for immediate application to clinical environments. .

次要结局

  • Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms questionnaire(4 weeks)

研究者

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

Mahmoud Awad Ramadan Elkholy

Lecturer of Physical Therapy for Integumentary System and burn disorders, Faculty of Physical Therapy ,Beni-Suef University

Beni-Suef University

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