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临床试验/CTRI/2024/04/065881
CTRI/2024/04/065881已完成2/3 期

Comparative study between Nanocrystalline silver dressing versus conventional dressings in Diabetic foot ulcers - A randomized control trial

DrRamkamal Balachandran1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月26日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Reduction in wound size

研究概览

简要总结

Diabetic foot ulcers are one of the most common complications of Diabetes mellitus with an incidence of almost 15% during the lifetime of a diabetic. Studies have shown that upto 80% of patients with diabetic foot ulcers suffer from both limb ischemia and peripheral neuropathy simultaneously. Individuals with diabetic foot ulcers are susceptible to infection and the healing process is complicated by diabetic neuropathy leading to chronic non-healing ulcers. Consequently more than 85% of lower limb amputations are preceded by foot or ankle ulcer and diabetes is one of the major causes of non-traumatic amputations across the world  Despite high prevalence and morbidity associated with diabetic foot ulcers, current treatment options are limited. The current standard of care consists of surgical debridement followed by frequent dressing changes with strict glycemic and infection control. These ulcers not only affect the quality of life and productivity of patients but also represent a substantial financial burden for the patient and the healthcare system.   Antiseptic agents are used in conjugation with dressings to control bacterial load and prevent the development of infection but may also be toxic to fibroblasts and other viable cells. However, silver only has a weak toxic potential and studies have demonstrated the effectiveness of silver-based dressings against pathogenic bacteria. The use of silver as a prophylactic and treatment for infections and other diseases dates back 1000 BC, when it was used as a disinfectant by the Greeks and Romans. Silver has antiseptic, antimicrobial, anti-inflammatory properties and is a broad spectrum antibiotic. The potency of silver as an antimicrobial was found to be related to the amount and rate of free silver released onto the wound bed. Advancements in Nanotechnology has allowed the production of very small sized silver particles with large surface area to volume ratios which imparts greater antimicrobial efficacy and lowers toxicity to human tissue.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • grade 1 and 2 wagners classification ulcer duration > 3 weeks able to understand procedure and provide consent.

排除标准

  • 1.patients with cardiac disease, HIV, Hepatitis, critically ill patients 2.pregnancy 3.chronic venous/arterial insufficiency ulcer 4.malignant ulcer 5.Hb <7g/dl 6.Known or suspected osteomyelitis 7.ulcer <2cm size.

结局指标

主要结局

Reduction in wound size

时间窗: Day-0, 1 week and 2 weeks

次要结局

  • Improvement in granulation formation(Day-0, 1 week & 2 weeks)

研究者

发起方
DrRamkamal Balachandran
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr.Ramkamal balachandran

Sri manakula Vinayagar medical college and hospital,Puducherry

研究点 (1)

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