Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedSeptember 4, 2018
August 1, 2018
5 months
November 8, 2016
August 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Correlation of OCT Measurement of blood vessel density at baseline, with rate of wound healing
16 weeks
Eligibility Criteria
Patients attending hospital outpatient, day care or inpatient clinic, \> 18 years and capable of giving informed consent.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Biospecimen
2 mm punch biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank L Bowling, PhD
Central Manchester University Hospital NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2016
First Posted
November 18, 2016
Study Start
October 1, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share