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临床试验/CTRI/2025/10/096176
CTRI/2025/10/096176尚未招募2 期

Added Effect of Russian Current Along With Standard Surgical Dressing for Healing, Foot Pressure and Functional Recovery in Diabetic Foot Ulcer: A Randomised Control Trial

Annie Fernandes2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年10月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
22
试验地点
2
主要终点
1)imito wound application

研究概览

简要总结

This randomized controlled trial aims to evaluate the added effect of Russian current stimulation along with standard surgical dressing in promoting wound healing, improving plantar foot pressure, and enhancing functional recovery in patients with diabetic foot ulcers. A total of 22 participants with Wagner Grade I and II diabetic foot ulcers will be randomly allocated into two groups: one receiving standard surgical dressing alone (control group) and the other receiving Russian current therapy in addition to standard dressing (intervention group). The study will be conducted over six months at a tertiary care hospital in Belagavi. Outcome measures will include wound healing assessed using the ImitoWound app, plantar pressure using the Diabetic Foot Analyzer, and quality of life using the Diabetic Foot Ulcer Scale (DFS-SF). The study hypothesizes that Russian current, through improved local circulation and muscle activation, will accelerate healing and functional recovery compared to standard care alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects with type 2 diabetes and having ulcers in lower limb region 2.Diabetic foot ulcer Grade 1 and 2 according to Wagner’s Classification 3.Participants willing to participate in the study
  • Participants with sensory integrity in the category of green and blue according to the WEST classification using monofilaments.

排除标准

  • 1.Cardiac pacemakers
  • Skin malignancies 3.Diabetic ketoacidosis
  • Complete sensory loss
  • Uncontrolled Diabetes status or fluctuating blood sugar.

结局指标

主要结局

1)imito wound application

时间窗: Before intervention and after 2 weeks of intervention

2)Diabetic foot analyser

时间窗: Before intervention and after 2 weeks of intervention

3)DFS-SF-quality of life scale

时间窗: Before intervention and after 2 weeks of intervention

次要结局

未报告次要终点

研究者

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

Vijay Kage

KAHER Institute of Physiotherapy

研究点 (2)

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