A Comparative Study of Faradic and Galvanic Stimulation on Wound Healing and Circulation in Diabetic Foot Ulcer -A Randomized Clinical Trial
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
Dr.Peeyoosha Gurudut
KLES Institute of physiotherapy belgaum
