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临床试验/CTRI/2025/10/096211
CTRI/2025/10/096211尚未招募不适用

A Comparative Study of Faradic and Galvanic Stimulation on Wound Healing and Circulation in Diabetic Foot Ulcer -A Randomized Clinical Trial

Self sponsored1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
IMITOMEASURE

研究概览

简要总结

TITLE  A COMPARATIVE STUDY OF FARADIC AND GALVANIC STIMULATION ON WOUND HEALING AND CIRCULATION IN DIABETIC FOOT ULCER A RANDOMAIZED CLINICAL TRIAL

Objective – To compare the effect of faradic and galvanic stimulation on wound healing and circulation using podological assessment tool and wound surface area by photography using imito app in participants with diabetic foot ulcer.

INCLUSION CRITERIA

Participants :-

·         Between the age group of 40-70 years.

·         Diagnosed with type 2 diabetes having ulcer and referred by surgeon.

·         Ulcer grade according to Wagner’s classification.[5]

·         With sensory integrity in the category of green and blue according to WEST classification using monofilament.[6]

·         Willing to participate in the study.

EXCLUSION CRITERIA

Participant :-

  • With cardiac pacemaker or any other implanted electronic devices hearing aids
  • Implants near ulcer area
  • Skin malignancies
  • Who have cognitive impairment
  • Uncontrolled diabetes status ( HbA1c – 10% or higher)
  • Contraindication of electrical stimulation

OUTCOME MEASURES:

  • IMITOMEASURE:- Measure Wound (app to measure wound)The imitoMeasure app is a helpful and practical way to measure an area that has high accuracy and repeatability. Imito is a noncontact digital planimetry app that offers a benefit over alternative techniques. The imitoMeasure app is a helpful and practical way to measure an area that has high accuracy and repeatability (ICC score :0.98)Assessment will be done 2 times that is pre and post by a qualified physiotherapist. Components are checked by wound area, circumference and depth

PODOLOGICAL ASSESSMENT TOOL [9,10]

It is tool used for the diagnosis of diabetic foot ulcers,there are various components are present, :

1.Biothesiometer – for vibration perception threshold (VPT) to

assess neuropathy.

2.Doppler probes – for vascular assessment.

3.Foot pressure measurement systems – for identifying high-risk plantar pressure zones

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Between the age group of 40-70 years.
  • Diagnosed with type 2 diabetes having ulcer and referred by surgeon.
  • Ulcer grade according to Wagner’s classification With sensory integrity in the category of green and blue according to WEST classification using monofilament Willing to participate in the study.

排除标准

  • With cardiac pacemaker or any other implanted electronic devices hearing aids Implants near ulcer area Skin malignancies Who have cognitive impairment Uncontrolled diabetes status HbA1c – 10% or higher Contraindication of electrical stimulation.

结局指标

主要结局

IMITOMEASURE

时间窗: imitomeasure and PODOLOGICAL Assessment Tool pre and post intervention (3weeks)

PODOLOGICAL ASSESSMENT TOOL

时间窗: imitomeasure and PODOLOGICAL Assessment Tool pre and post intervention (3weeks)

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr.Peeyoosha Gurudut

KLES Institute of physiotherapy belgaum

研究点 (1)

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