NCT04207099已完成不适用
A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
研究概览
简要总结
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.
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
- •Male or female patients presenting with chronic DFU
- •The chronic DFU has a surface area that has reduced <25% in the previous 4 weeks1 prior to first study visit
- •Patient has been receiving treatment for their DFU for less than 12 weeks.
- •The chronic DFU is > 1 cm2 in area and less than 15 cm in length (max. diameter)
- •18 years or older
- •Willing and able to make all required study visits
排除标准
- •• Patients categorized as having a maintenance wound
- •Use of skin substitutes or hyperbaric oxygen therapy or surgical intervention
- •Treatment with an investigational drug within 1 month of enrolment
- •Presents with chronic (>10 mg/kg for >30 days) systemic corticoids before enrolment
- •Has ABI <0.5 (measured within 3 months of randomisation)
- •Undergoing chemotherapy or is immunocompromised
- •Diagnosed with Charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis
- •Recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment
- •Inability or unwillingness to consent
结局指标
主要结局
Rate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
时间窗: 5 months
ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period
次要结局
- Wound Healing Rate(5 months)
研究者
研究点 (5)
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