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临床试验/NCT05410613
NCT05410613Unknown不适用

Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer

Mona Mohamed Taha1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Ulcer volume measurement

研究概览

简要总结

The purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg 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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • patients with venous leg ulcer

排除标准

  • patients who have one or more of the following conditions:
  • peripheral vascular disease (PVD), (ABPI<0.8).
  • venous leg ulcers with cellulitis or infection symptoms, as well as venous leg ulcers with necrotic tissue or slough or had more than one ulcer.
  • other types of ulcers, such as rheumatoid vasculitis, diabetic foot, and malignant ulceration; corticosteroids use ; patients with dementia or who were disoriented;
  • undertaken another physical therapy modality for ulcer healing.

结局指标

主要结局

Ulcer volume measurement

时间窗: two months

Ulcer volume : The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width. * A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth. * (Width x length x depth) would be calculated to have the volume of the ulcer

Pressure Ulcer Scale for Healing (PUSH)

时间窗: two months

Categorize the ulcer with respect to surface area, exudate, and type of wound tissue

Ulcer surface area

时间窗: two months

Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker.

次要结局

未报告次要终点

研究者

发起方
Mona Mohamed Taha
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mona Mohamed Taha

associate professor

Cairo University

研究点 (1)

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