CTRI/2022/04/041745已完成4 期
An open label, multicentre, randomized phase IV clinical trial to evaluate the safety and efficacy of MaxioCel compared with Aquacel Extra for the management of exuding chronic wounds.
Axio Biosolutions Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male or female 18 years old or above
- •2) Patients who are willing to sign the written informed consent
- •3) Clinically diagnosed with an unhealed or non-healing diabetic foot
- •ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.
- •4) Wound duration between 1 to 24 months
- •5) A target wound area between 1 cm2 and 50 cm2
- •6) Exuding wounds / ulcers
排除标准
- •1) Known allergy/hypersensitivity to the dressing
- •2) Pregnant women
- •3) Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study’s clinician
- •4) Dry wounds
- •5) Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics
- •6) Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy
- •7) Patients who had Deep Vein Thrombosis in the previous 3 months
- •8) Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm
- •9) Subjects included in clinical study at present or during the past 30 days
- •10) Clinical suspicion of osteomyelitis
研究者
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