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临床试验/CTRI/2024/05/068228
CTRI/2024/05/068228尚未招募4 期

A study comparing the efficacy of tertiary ammonium compound based foam dressing versus silver based foam dressing in non ischemic diabetic foot ulcer patients using wound ischemia foot infection grading WIFI GRADE 2 in a tertiary care hospital

Shahala Shirin T P1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年6月12日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
Time duration needed for complete wound healing

研究概览

简要总结

There are multiple factors associated with the development of diabetic foot ulcer , such as the complex process and complications of diabetes, may all lead to various degrees of neurological abnormalities and vascular damage. once the ulcer is formed, the factors affecting healing may be more complex, and different factors may dominate at different stages over time. thus, these related factors play different roles depending on the severity of disease and duration of recovery, necessitating different diagnoses and treatments for seemingly the same symptoms and causing differences in the curative effect. in these circumstances, the classification and scoring criteria for describing lesions of diabetic foot                           ulcer should be formatted in a manner that is clinically recognized and widely used, which will allow characterization of diabetic foot ulcer on the basis of differences and facilitate suggestions for treatment or care programs.

Silver based foam dressings can continuously and effectively release silver ions, kill the wound and surrounding bacteria, improve the wound healing environment, and can also hydrate and soften necrotic tissue and clean the wound. silver ions can bind to negatively charged bacteria, enhance the permeability of the bacterial outer membrane, and induce bacterial apoptosis. the silver dressing has a certain toxic effect on fibroblasts of diabetic patients, which can reduce its cell activity and collagen synthesis, and significantly change cell morphology. some studies have found that silver dressings significantly reduce odour, improve pain-related symptoms, decrease wound exudate, and have a prolonged dressing wear time.

Recently, dimethyl tetradecyl ammonium chloride (DTAC) based 3d-hydrocellular wound dressings have emerged. DTAC is a cationic surfactant used at the concentration of 1% w/w,  based on DTAC technology, 3d-hydrocellular wound dressing is formulated as a 3- dimensional knitted fabric. The 3-dimensional knitted fabric comprises of DTAC-bounded polyethylene terephthalate (90% w/w) and polyurethane material (10% w/w), forming a 3D hydrocellular structure. DTAC-based dressing acts as a physical barrier against contaminants, helps in gaseous exchange, maintains the moist environment, and manages the exudates effectively. They are primarily used for exuding, minor, chronic and surgical wounds, and first and second-degree burns. The exceptional properties of DTAC technology are the “physical kill mechanism” for microbial protection and the non-leachability of DTAC into the skin or out  of the dressing. The cross-linking property ensures that the active component remains bounded to the surface of the dressing. in addition, the DTAC dressings as antimicrobial, cover a broad spectrum of microbes and eradicate the infection load at the wound site

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 75.00 Year(s)(—)
性别
All

入选标准

  • Grade 2 diabetic foot ulcer satisfying WIFi classification
  • Willing to give written informed consent for the study.

排除标准

  • Diabetic foot ulcers with underlying ischemia, neuropathy
  • All causes of foot ulcer, which can be attributed to other coexisting diseases like paraplegia, varicose vein, etc.
  • Patient with known hypersensitivity to ammonium or ionic silver.

结局指标

主要结局

Time duration needed for complete wound healing

时间窗: Weekly until complete healing or 6 months post dressing

次要结局

  • Number of debridement and dressings needed(Weekly until complete healing or 6 months post dressing)
  • Cost efficacy(After complete healing or 6 months)
  • Presence of slough as percentage of total ulcer surface area(Weekly until complete healing or 6 months post dressing)
  • Presence of granulation as percentage of total ulcer surface area(Weekly until complete healing or 6 months post dressing)

研究者

发起方
Shahala Shirin T P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shahala Shirin T P

Government medical college Kozhikode

研究点 (1)

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