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Trial record 1 of 1 for:    NCT02317835
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Diabetic Foot Ulcer Prevention System (DFUPS)

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ClinicalTrials.gov Identifier: NCT02317835
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : June 9, 2016
Sponsor:
Collaborators:
National Physical Laboratory
University of South Wales
Freeman Health System
Pennine Acute Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Photometrix
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Device: DFUPS Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study in healthy volunteers
Skin foot temperature measurement by DFUPS device
Device: DFUPS
The DFUPS device is a two-camera instrument for capturing images of feet




Primary Outcome Measures :
  1. Detection of hot spots on a foot thermal map image [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 18 years or older
  2. Has no history of diabetes
  3. Has no previous history of foot ulceration
  4. Has no previous history of foot surgery
  5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
  6. Has no history of peripheral neuropathy
  7. Has no history of peripheral arterial disease
  8. Must be able to provide meaningful written informed consent for the study

Exclusion Criteria:

  1. Has active foot ulceration and infection
  2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
  3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
  4. Has an implantable electronic device
  5. Is aged <18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317835


Locations
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United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
The Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom, M9 4BE
The Newcastle upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom, NE3 3HD
Sponsors and Collaborators
King's College Hospital NHS Trust
National Physical Laboratory
University of South Wales
Freeman Health System
Pennine Acute Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Photometrix

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02317835    
Other Study ID Numbers: version 2 (02/3/2015)
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases