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临床试验/CTRI/2025/05/086318
CTRI/2025/05/086318招募中2/3 期

An Open-Label Add-On Randomized Controlled Trial to Assess the Efficacy of Deep Tissue Heating as an Adjuvant Therapy in Patients with Severe Diabetic Foot Ulcers

College of Medicine and Sagore Dutta Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月19日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Improved healing rate, healing time, infection rate, amputation rate.

研究概览

简要总结

The standard treatment guidelines for the prevention and management of diabetic foot include conventional treatments such as infection management and surgical interventions. Improvement of blood blow rates in the affected peripheral tissues of the body improves the accessibility of drugs and tissue repair proteins and potentially reduces the wound healing time. This adjuvant therapy would potentially provide a faster therapeutic solution for DFUs.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Individuals with diabetic foot ulcers.

排除标准

  • Individuals with severe comorbidities.

结局指标

主要结局

Improved healing rate, healing time, infection rate, amputation rate.

时间窗: Weekly monitoring from baseline. Comparison every 4 weeks.

次要结局

  • Wound healing rate, infection rate, amputation rate, all cause mortality.(Baseline, 8 Weeks, 6 months.)

研究者

发起方
College of Medicine and Sagore Dutta Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Subhasish Sarkar

College of Medicine and Sagore Dutta Hospital

研究点 (1)

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