Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies

Completed

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT02967900
• Lead Sponsor: Michelson Diagnostics Ltd.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Study Start: 2017-10-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of OCT Measurement of blood vessel density with rate of wound healing	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing	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.

Trial Locations

Locations (1)

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom