Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies

Conditions
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Diabetic Foot Ulcer

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of OCT Measurement of blood vessel density with rate of wound healing | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing | 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 |