NCT06682923已完成不适用
Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler
研究概览
简要总结
This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.
详细描述
The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to consent
- •Willing to comply with all study procedures and availability for the duration of the study
- •Male or female, aged over 22 years old
- •Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
- •Wound size is greater than 0.5 cm2
- •The wound has well-defined wound borders
排除标准
- •Circumferential wound
- •Wound without clearly defined wound borders
- •Wound located in a difficult to reach/measure location
- •Any contra-indication to routine wound care and/or monitoring
- •Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
- •Tunneled or undermined wounds
结局指标
主要结局
Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler
时间窗: up to 6 months
次要结局
- Mean and standard deviation of inter- and intra-user coefficient of variation (CV) for wound area measured by the MolecuLight device in manual and automaitc modes(up to 6 months)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
不适用
Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound DebridementInfection, Surgical SiteNCT04541394Taipei Medical University Shuang Ho Hospital200
已完成
不适用
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic PeriodontitisPeriodontitisNCT05278416Koite Health Oy202
进行中（未招募）
3 期
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).Superficial Basal Cell CarcinomaNCT03573401Biofrontera Inc.187
已完成
2 期
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in AdultsAcne VulgarisNCT05080764Biofrontera Inc.120
已完成
不适用
Blu Light for Ulcers ReductionLeg Ulcers VenousDehiscence, Surgical WoundNCT04018924Emoled90