Diabetic Foot Ulcer Prevention System

Diabetic Foot Clinical Trial

— DFUPS  

Official title:

An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317835
• Other study ID #: version 2 (02/3/2015)
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2014
• Last updated: June 8, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• DFUPS
The DFUPS device is a two-camera instrument for capturing images of feet

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United Kingdom	The Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	The Newcastle upon Tyne Hospitals	Newcastle upon Tyne

Sponsors (7)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Freeman Health System, National Institute for Health Research, United Kingdom, National Physical Laboratory, Pennine Acute Hospitals NHS Trust, Photometrix, University of South Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of hot spots on a foot thermal map image		9 months	No