Conventional silver colloidal dressing combined with local insulin application VS negative pressure wound therapy in regular management of diabetic foot ulcer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To determine the efficacy of negative pressure wound therapy (NPWT) in promoting wound healing of diabetic foot ulcer Vs Conventional silver colloidal dressing combined with local application of insulin.
研究概览
简要总结
After written informed consent is obtained, data will be collected from suitable patients according to the inclusion and exclusion criteria n the department of general surgery KH Manipal. Appropriate history is taken and measurements of ulcer are documented using sterile paper ruler. Wound size is calculated by taking longest diameter (a) in mm and multiplying with its perpendicular diameter (b) and the depth (c) so that the total volume of the wound is obtained in mm3. 29 subjects will be included in each group. In group 1 -Patient will be treated with silver colloidal combined with local application of insulin daily dressing and wound will be assessed on day 8. In group 2 Patient will be treated with NPWT and wound will be assessed on day 8. The outcome will be measured based on percent reduction in wound size between group 1 and group 2. Rate of wound healing is calculated as difference between the wound volume on day 0 and day 8 and is reported in terms on mm3. Data is tabulated and percentage reduction in the size of the ulcer is compared.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic patient 2) Willing to participate in study 3) Grade 2 3 4 Diabetic foot ulcer according to Wagner classification.
排除标准
- •Non diabetic foot ulcer.
- •Grade 1 and 5 Diabetic foot ulcer according to Wagner classification 3) Pregnant women 4) Necrotic tissue with existing eschar that could not be debrided.
- •Bleeding disorders.
- •Peripheral vascular disease or monophasic on doppler 7) Patient with proven venous ulcer and malignancy.
结局指标
主要结局
To determine the efficacy of negative pressure wound therapy (NPWT) in promoting wound healing of diabetic foot ulcer Vs Conventional silver colloidal dressing combined with local application of insulin.
时间窗: Wound will be inspected on day 0 and day 8
次要结局
- total cost in treatment.(total cost will be calculated on day 8)
研究者
Dr Arohi Utkarsh
Kasturba hospital, Manipal