CTRI/2021/08/035724尚未招募不适用
An interventional study of surgical offloading procedures in chronic non-healing diabetic foot ulcers in a tertiary care hospital in puducherry
Sri Venkateshwaraa Medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decreased pressure in the concerned area and thereby ulcer healing and reduced recurrence
研究概览
简要总结
Each patient will be enrolled based on the inclusion and exclusion criteria. After getting written informed consent, a detailed history is ellicited and examination is done and all the details will be entered in a pre structured proforma. After performing routinr investigations and pre-operative pedobarogram, pre anaesthetic fitness is obtained and surgical offloading is done. Post operative pedobarogram is done and patient is followed up for a period of 6 months to estimate the healing rate and recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Toe ulcer, forefoot ulcer, midfoot ulcer, hindfoot ulcer 2)Non-healing ulcers 3)Fit for surgery and anaesthesia 4)Controlled blood sugar levels.
排除标准
- •Acute infective ulcer 2)Uncontrolled blood sugar levels 3)Associated peripheral vascular disease 4)Underlying cardiac, pulmonary or renal disease.
结局指标
主要结局
Decreased pressure in the concerned area and thereby ulcer healing and reduced recurrence
时间窗: 6 months
次要结局
- Decreased ulcer recurrence(6 months)
研究者
研究点 (1)
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