NCT07438951尚未招募不适用
A Prospective, Multi-Centre, Observational, Real World Evidence Study on the Efficacy and Safety of a Nitric Oxide Generating Dressing (ConvaNiox™) in the Treatment of Diabetes Related Foot Ulcers (DFUs).
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Percentage area reduction
研究概览
简要总结
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IC-1 - Subjects at least 18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study
- •IC-2 - The subject must have either type 1 or type 2 diabetes and a diabetes-related ulcer meeting all the following characteristics:
- •IC-2a Classified as University of Texas (UT) Classification Grade 1 stages A-D IC-2b At or below the level of malleolus IC-2c Neuropathic or neuroischemic etiology confirmed through Electronic Medical Records (EMR) IC-2d Ulcer surface area between ≥1 and ≤25 cm² IC-2e For subjects who have more than one ulcer, the largest ulcer will be the study ulcer
- •IC-3 Non-infected and infected ulcers are eligible for inclusion, with infection being classified using the International Working Group on the Diabetic Foot (IWGDF) Infection guidelines.
- •Only PEDIS 2 infections are permitted - Mild superficial skin and soft tissue infections with no systemic manifestations and involving:
- •Erythema extending ≥2 cm from the wound margin, and/or tissue deeper than skin and subcutaneous tissues (e.g., tendon, muscle, joint, and bone)
- •IC-4 Adequate arterial supply in the lower extremity as defined by Wound, Ischemia, foot Infection (WIfI) Ischemia grade 0-1;
- •Palpable foot pulse with biphasic or triphasic pedal Doppler waveforms, AND
- •Ankle Brachial Index (ABI) >0.6 OR Toe Brachial Index (TBI) >0.5, OR
- •Toe pressure >40mmHg
排除标准
- •EC-1 Ulcers that are tunnelling or have cavities (>10mm in depth)
- •EC-2 An ulcer that is actively bleeding. Subjects may be re-screened once active bleeding has stopped
- •EC-3 Subjects taking any medication known to inhibit wound closure including chemotherapy and immunomodulatory biological agents. The use of systemic corticosteroids <10mg/kg/day is permitted
- •EC-4 Active Charcot foot
研究组 & 干预措施
Subjects with non-healing diabetes-related foot ulcers, treated with ConvaNiox
干预措施: ConvaNiox (Device)
结局指标
主要结局
Percentage area reduction
时间窗: at 12 weeks
次要结局
- Incidence of wound closure(at 12 weeks)
- Percentage area reduction(at 4 weeks)
- Incidence of >50% percentage area reduction(at 4 weeks)
研究者
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