Diabetic Foot Ulcer Prevention System
DFUPS
An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
1 other identifier
interventional
105
1 country
3
Brief Summary
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2015
3 active sites
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
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 9, 2016
June 1, 2016
5 months
December 10, 2014
June 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Detection of hot spots on a foot thermal map image
9 months
Study Arms (1)
Study in healthy volunteers
OTHERSkin foot temperature measurement by DFUPS device
Interventions
The DFUPS device is a two-camera instrument for capturing images of feet
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Has no history of diabetes
- Has no previous history of foot ulceration
- Has no previous history of foot surgery
- Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
- Has no history of peripheral neuropathy
- Has no history of peripheral arterial disease
- Must be able to provide meaningful written informed consent for the study
You may not qualify if:
- Has active foot ulceration and infection
- Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
- Has an implantable electronic device
- Is aged \<18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Hospital NHS Trustlead
- National Physical Laboratorycollaborator
- University of South Walescollaborator
- Freeman Health Systemcollaborator
- Pennine Acute Hospitals NHS Trustcollaborator
- National Institute for Health Research, United Kingdomcollaborator
- Photometrixcollaborator
Study Sites (3)
King's College Hospital
London, SE5 9RS, United Kingdom
The Pennine Acute Hospitals NHS Trust
Manchester, M9 4BE, United Kingdom
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE3 3HD, United Kingdom
Related Publications (1)
Petrova NL, Whittam A, MacDonald A, Ainarkar S, Donaldson AN, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds ME. Reliability of a novel thermal imaging system for temperature assessment of healthy feet. J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.
PMID: 29854007DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 17, 2014
Study Start
July 1, 2015
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
June 9, 2016
Record last verified: 2016-06