Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Correlation of OCT Measurement of blood vessel density with rate of wound healing
研究概览
简要总结
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Correlation of OCT Measurement of blood vessel density with rate of wound healing
时间窗: 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.
次要结局
- Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing(16 weeks)