跳至主要内容
临床试验/CTRI/2025/02/080589
CTRI/2025/02/080589尚未招募不适用

Impact of Nanofat grafting on healing outcomes in chronic non-healing wounds: A randomized, controlled study

DY Patil Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1. Faster healing of chronic and acute wounds and ulcer in nanofat graft vs standard care

研究概览

简要总结

Chronic non-healing wounds pose significant challenges in clinical care, leading to prolonged morbidity and substantial healthcare costs. Emerging therapies, such as nanofat grafting, have shown promise due to their regenerative potential. Nanofat is derived from adipose tissue and contains a high concentration of stromal vascular fraction (SVF) cells, including mesenchymal stem cells, which possess anti-inflammatory, angiogenic, and wound-healing properties.

This randomized controlled trial aims to evaluate the efficacy of nanofat grafting in improving healing outcomes for chronic non-healing wounds compared to standard wound care. The study includes patients with chronic wounds, such as diabetic foot ulcers and venous leg ulcers, who are randomized into two groups: one receiving nanofat grafting and the other receiving standard care alone. Key outcomes include wound closure rate, time to complete healing, reduction in wound size, pain scores, and improvement in quality of life.

Preliminary data suggests that nanofat grafting can accelerate wound healing by enhancing angiogenesis, reducing inflammation, and promoting tissue regeneration. This trial aims to provide robust evidence to support the integration of nanofat grafting into clinical practice for chronic wound management.

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

  • subject with acute/chronic wound or ulcers wounds with adequate arterial blood supply in the target limb adequately debrided wound without any slough.

排除标准

  • severe debility Patients on ventilator support Are pregnant or lactating Have a known allergy or are sensitive to any dressing material Have a known or suspected disease of the immune system Have has had surgery in past 30days to increase blood flow into your leg or foot Patients who refused to give consent.

结局指标

主要结局

1. Faster healing of chronic and acute wounds and ulcer in nanofat graft vs standard care

时间窗: check dressing will be done on Post Operative Day 3. Followed by 6th day and 9th then in 2nd week, 3rd week and 4th week.

2. Reduce size of wound in nanofat graft vs standard care

时间窗: check dressing will be done on Post Operative Day 3. Followed by 6th day and 9th then in 2nd week, 3rd week and 4th week.

次要结局

  • Safety in nanofat graft vs standard care(2 weeks)

研究者

发起方
DY Patil Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vinitha Nair

Padmashree Dr. DY Patil School of medicine

研究点 (1)

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