Digital Techniques for Measuring Chronic Leg Ulcers in Peripheral Arterial Disease: Aspects of Measurement Precision and Evaluation of Wound Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- To assess the clinical agreement between two methods of measuring the depth of arterial wounds, we will utilize the Bland-Altman plot.
研究概览
简要总结
The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Adults with peripheral arterial disease.
- •Arterial or arteriovenous ulcers on lower leg
排除标准
- •Adults with non-ischemic ulcers,
- •Purely venous ulcers,
- •Purely traumatic wounds,
- •Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis),
结局指标
主要结局
To assess the clinical agreement between two methods of measuring the depth of arterial wounds, we will utilize the Bland-Altman plot.
时间窗: Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
The Depth of the wound will be determined using two different measurement techniques, with measurement taken during a single session. 1. Manual Depth Measurement with a Cotton Swab: A cotton swab is inserted into the wound to measure its depth. The measurement is taken at the deepest point and recorded in millimeters (mm). 2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the depth of the wound in millimeters (mm).
To assess the clinical agreement between two methods of measuring arterial wound size, we will utilize the Bland-Altman plot.
时间窗: Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
The size of the wound will be determined using three different measurement techniques, with images captured during a single session. 1. Traditional Method for Area Measurement: This method utilizes a Canon EOS 700D camera and a 10 cm ruler for reference. The area is calculated using Picsara software, yielding results in square centimeters (cm²). 2. SeeWound Method Version 1.6.4 for Area Measurement with reference card: This technique employs a specialized app to calculate the wound area in square centimeters (cm²) with the reference card. 2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the area in square centimeters (cm²).
次要结局
未报告次要终点
研究者
Louise Koch-Nielsen
Specialist nurse, PhD student
Sahlgrenska University Hospital, Sweden