Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
研究概览
地位
条件
详细说明
Diabetic foot ulcers are a major burden on the healthcare system, and it is highly desirable to develop a practical, reliable, non-invasive means of diagnosing, assessing and measuring wound healing, so as to provide wound care specialists with key data with which to make effective decisions for clinical management.
Optical coherence tomography (OCT) is a novel technique of imaging of cutaneous tissue. Using low-power infrared light, it is a non-invasive in-vivo imaging technique which provides resolution of <10microns to a depth of 1 - 1.25 mm in skin, (adequate to resolve capillaries) utilizing the optical scattering characteristics of tissue to provide imaging contrast.
This open, non-randomised, observational study will assess the feasibility of using OCT to diagnose chronic diabetic foot ulcers. One cohort of 15 patients will be scanned over a 16 week period and results studied to determine whether there is an association between rate of wound healing and OCT measurements.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Manchester、英国、M13 9WL
- Manchester Royal Infirmary
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Defining ABPI ≥0.5 - <1.2
- Patients with DFU for over 4 weeks but less than 1 year duration. DFU resulting from neuropathy will be included.
- Neuropathy scores defined by 10g Semmes-Weinstein monofilament tests at 10 sites on plantar and dorsal surfaces
Exclusion Criteria:
- Patients with uncontrolled diabetes, the Charcot Foot, cancer (except non-melanoma skin cancer in the limb), decompensated cardiac failure, clinically significant renal failure, history of stroke or significant peripheral arterial disease, or those who are pregnant, or on a waiting list for interventional therapy.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of OCT Measurement of blood vessel density with rate of wound healing
大体时间：16 weeks
|
Pearson's coefficient of correlation between the OCT measurement of blood vessel density (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow) and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound per 4 week period), as an average across all trial subjects and all measurement points during the trial. Pearson's coefficient > 50% signifies a positive result. |
16 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing
大体时间：16 weeks
|
Pearson's coefficient of correlation between the OCT measurement of blood vessel density at baseline, (fraction of the imaged skin volume in the upper 0.5 mm of tissue that is comprised of vessels with detectable blood flow), and the rate of wound healing (defined as the magnitude of reduction in measured area of the wound over the 16 week trial period), as an average across all trial subjects. Pearson's coefficient > 50% signifies a positive result. |
16 weeks
|
合作者和调查者
调查人员
- 首席研究员：Frank L Bowling, PhD、Central Manchester University Hospital NHS Foundation Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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