跳至主要内容
临床试验/CTRI/2025/11/098202
CTRI/2025/11/098202尚未招募2 期

Effect of i-Coll- collagen particles on wound healing dynamics of chronic leg ulcers.

IWound Global Private Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月8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
30
试验地点
1
主要终点
Rate of Wound Contraction

研究概览

简要总结

Chronic leg ulcers, including diabetic, venous, and pressure ulcers, are major public health concerns causing significant morbidity, pain, and disability. Delayed healing in such ulcers often results from impaired collagen synthesis and tissue remodeling. Collagen-based therapies have shown promise in enhancing wound repair by supporting cellular proliferation and extracellular matrix formation.

This interventional study aims to evaluate the efficacy of i-Coll collagen particles on wound healing dynamics in patients with chronic leg ulcers. A total of 30 participants with non-healing ulcers of more than three months’ duration will be recruited and receive i-Coll collagen particle application every 48 hours for 21 days, along with standard wound care practices.

The primary outcome is the rate of wound contraction, assessed by planimetric and photographic measurements. Secondary outcomes include hydroxyproline and hexosamine content in wound swab samples, reflecting biochemical markers of collagen synthesis and healing.

It is hypothesized that i-Coll collagen particles, due to their native triple-helical protein structure, will enhance granulation tissue formation, accelerate epithelialization, and promote faster wound closure compared to standard treatment. The findings are expected to provide evidence for the therapeutic role of collagen-based formulations in 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

  • Patients above 18 years of age, either gender.
  • Presence of chronic non-healing foot ulcer (Venous, pressure and diabetic foot ulcer).

排除标准

  • Individuals under the age of 18, those with foot ulcers referred to surgical interventions will be exempted from participation.

结局指标

主要结局

Rate of Wound Contraction

时间窗: Measured as the percentage reduction in ulcer area over the treatment duration (21 days), using sequential photographic and assessment.

次要结局

  • Hydroxyproline and Hexosamine Content of the Wound

研究者

发起方
IWound Global Private Limited
申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr G Arun Maiya

Manipal College of Health Professions, MAHE, Manipal

研究点 (1)

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