NCT02967900

Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Michelson Diagnostics Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-11-18
• Last updated: 2018-09-04

Locations

1 site across 1 country: United Kingdom