CTRI/2023/06/054116已完成3 期
An Open, Non-Randomized, Single arm, Single centricClinical trial to determine the effectiveness of Wound dressing with Punga Thailam in the management of Madhumega viranam (Diabetic Foot Ulcer)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Outcome will be measured with the use of leg ulcer measurement tool.
研究概览
简要总结
It is an open non randomized, single arm, single centric, trail to determine the therapeutic effectiveness of punga thailam in the management of madhumega viranam (diabetic foot ulcer). Patients with diabetic foot ulcers will be enrolled for the study as per inclusion and exclusion criteria. After the enrollment, treatment will be given with punga thailam. Regular wound dressing will be done, and the ulcer will be assessed weekly with the use of leg ulcer measurement tool.
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
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Age: >18 years Sex: Male, Female and Transgender Superficial ulcer, Destruction of the thickness of the skin/ Penetrates through skin not affecting bone (Wagner’s Classification I & II) Willing to give specimen of blood for the investigation.
- •Willing to take photograph.
- •Willing to participate in trial by signing the informed consent.
- •Good control of Diabetes Mellitus.
排除标准
- •Ischemic foot Deep Ulcer (cellulitis) / Osteomyelitis with Ulceration or abscess/ Gangrenous patches limited to toes or part of the foot/ Gangrene of the entire foot (Wagner’s classification II, III, IV & V) Varicose ulcer Hansen’s disease Tuberculous ulcer Any active neoplastic disease Necrotizing fasciitis The patient who has uncontrolled diabetes will be treated for diabetes mellitus and after that he/she will be included for this study.
结局指标
主要结局
Outcome will be measured with the use of leg ulcer measurement tool.
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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