Comparative study between Nanocrystalline silver dressing versus conventional dressings in Diabetic foot ulcers - A randomized control trial
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
Dr.Ramkamal balachandran
Sri manakula Vinayagar medical college and hospital,Puducherry
