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临床试验/CTRI/2025/12/098261
CTRI/2025/12/098261已完成不适用

A study to assess the effectiveness of Buerger- Allen exercise on lower extremity perfusion, peripheral neuropathy symptoms and risk for development of foot ulcer among patients with Diabetes Mellitus at selected hospitals of Mullana, Ambala, Haryana

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Dependent variable: Lower extremity perfusion, Peripheral Neuropathy symptoms and Risk for development of foot ulcer

研究概览

简要总结

Patient with Diabetes Mellitus is at increased risk of developing peripheral vascular disease, leading to reduced lower extremity perfusion (LEP) and peripheral neuropathy symptoms (PNS). Impaired circulation in lower limbs may further increase risk for development of foot ulcer. Improvement of blood circulation through non- pharmacological management plays a significant role in preventing these complications among individual with Type 2 Diabetes Mellitus. The Buerger- Allen exercise is one such intervention aimed at stimulating and developing collateral circulation thereby enhancing LEP, reducing PNS, minimizing the risk of foot ulcer formation. The study includes two groups: an experimental and a control group. On Day 1 pretest is done, the experimental group receives the Buerger- Allen exercise intervention on Day 1 to Day 6, while control group receives only routine care without the exercise and post-test is conducted on Day 6.  The data collection is done using standardised tools in which tool 1 - Foot perfusion parameters are assessed using Ankle brachial index to assess the lower extremity perfusion , tool 2- Michigan Neuropathy screening instrument (MNSI)- to evaluate peripheral neuropathy symptoms and tool 3 - NMAHS ( Modified North Metropolitan Area Health Service East diabetes foot screening and observation tool) - to assess the risk for development of foot ulcer. Dependent variables for the study- lower extremity perfusion, peripheral neuropathy symptoms and risk for development of foot ulcer.

Recruitment and data collection have been completed. Data analysis is in progress

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
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients with Diabetes Mellitus -Age more than or equal to 18 years, willing to participate in study , available during the study period.

排除标准

  • Patients with Diabetes Mellitus-having foot ulcer or foot gangrene, critically ill, having Deep Vein Thrombosis (DVT).

结局指标

主要结局

Dependent variable: Lower extremity perfusion, Peripheral Neuropathy symptoms and Risk for development of foot ulcer

时间窗: Day 1- Pretest | Day 2- Post test

(Improvement in Lower extremity perfusion, Reduction in Peripheral Neuropathy symptoms and decrease in risk for development of foot ulcer)

时间窗: Day 1- Pretest | Day 2- Post test

次要结局

  • Not applicable(Not applicable)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Kalpana

Maharishi Markendeshwar College of Nursing, Mullana, Ambala

研究点 (1)

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