A prospective, single-arm study to assess the effectiveness and safety of Theruptor Novo dressing pad in the treatment of chronic lower extremity wounds

Dr Sanjay Sharma0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•1. Male and female patients aged above 18 years with <= 3 wounds in the lower extremity considered for the study
•2. Patient with a low to moderate exuding lower extremity wound with size <= 8 cm Ã? 8 cm, with less than 50% of contraction in the past 4 weeks even after standard treatment
•3. Patient willing to give written informed consent and adhere to study procedures

•1. Patients with wounds caused by venous or arterial insufficiency, or electrical or chemical burns
•2. Patients with wounds showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
•3. Patients with history of active Charcoatâ??s foot of the study foot within 6 months of screening
•4. Patients with severe or poorly controlled diabetes mellitus with severe hyperglycaemia (HbA1C >12%)
•5. Patients with progressive weight loss
•6. Patients undergoing treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, or radiotherapy
•7. Patients with history of other diseases, which can alter the normal healing of the wound such as connective tissue disease, renal failure, liver failure, and malignancy
•8. Patients who underwent revascularization surgery in the last 8 weeks
•9. Patients with ankle-brachial index(ABI) < 0.7
•10. Pregnant or lactating mothers

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