Clinical trial NCT02967900: Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
Official title: Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: Michelson Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2016-11-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending hospital outpatient, day care or inpatient clinic, \> 18 years and capable of giving informed consent.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of OCT Measurement of blood vessel density with rate of wound healing
timeFrame: 16 weeks
Secondary outcomes:
measure: Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Central Manchester University Hospital NHS Foundation Trust
name: Frank L Bowling, PhD
role: PRINCIPAL_INVESTIGATOR
References: