Three-dimensional Measurements for Monitoring Wound Healing of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Wound healing change quantified using the 3D-WAM camera
研究概览
简要总结
Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the ulcer is one of the major etiologic factors for delayed healing. Wound measurement is important in the monitoring of the wound healing process. For the last decade different 3D (three-dimensional) techniques for measuring wounds have been proposed in order to measure wound volume, but none of the technologies have been widely used. A 3D Wound Assessment Monitor (WAM) camera has been developed, which is able to measure wound size in 3D and to assess wound characteristics.
The investigators hypothesize that three-dimensional measurements of diabetic foot ulcers are feasible in the assessment of wound healing. A prospective cohort study is conducted in which newly admitted patients with a diabetic foot ulcer are included at the first visit at the multidisciplinary clinic. The patients are followed for one year or until complete wound healing, amputation or death. The four wound measurements: 2D area, 3D area, perimeter and volume are measured using the 3D-WAM camera with frequent intervals. Patient anthropometrics and wound data are collected during the study and correlated to the wound healing.
详细描述
Method
Newly admitted patients with a diabetic foot ulcer are included at the first visit in the multidisciplinary clinic. The data mentioned below are collected at the first visit and the following examinations are performed including 3D photos. The wound size (2D area, 3D area, perimeter and volume) are estimated from the photos using the 3D-WAM camera. The wound examination is repeated after 2, 4, 8, 12, 24, 36 and 52 weeks or until healing of the wound. The wound healing is estimated using changes in wound size per time unit. Patients are treated by standard ulcer treatment methods and are unaffected by the project per se. During the trial the different methods of treatment are noted including changes from initial treatment. The variables will be quantified after one year depending on time to heal, establishment of a chronic ulcer (non-healing after one year) or an amputation has been performed.
At baseline the following patient data will be collected:
- Demographic data: gender, age
- Smoking habits
- Time period between onset of wound to first visit in the multidisciplinary clinic
- Body Mass Index
- Comorbidity using Charlson Comorbidity Index score
- Type of diabetes, duration of diabetes
- Diabetic complications including retinopathy, albuminuria, coronary heart diseases and neuropathy
The following examinations will be performed at baseline:
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
- •Newly admitted patients with diabetic foot ulcers
- •18 years or older
排除标准
- •Superficial wound (less than 5x5 mm with no substantial loss of subcutaneous tissue)
- •Non-compliance (dementia, mental disorders)
结局指标
主要结局
Wound healing change quantified using the 3D-WAM camera
时间窗: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
The 3D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.
Wound healing change quantified using digital imaging method
时间窗: Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks
The 2D wound measurements at week 2, 4, 8, 12, 24, 36 and 52 are compared to the baseline measurement at week 0.
次要结局
- The variability in 2D area and 3D area measurements(Photos are taken at week 0, 2, 4, 8, 12, 24, 36 and 52 weeks)
- Diabetes type is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- Diabetes duration is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- BMI (kg/m2) is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- Charlson index score is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- HbA1c is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- Ischemia is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- Neuropathy is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
- Wound duration is compared to outcome of the wound(Baseline until healing, amputation or chronic wound (52 weeks))
研究者
Line Bisgaard Jørgensen
MD, PhD student
Odense University Hospital