Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2 (DFUPS)

Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at High Risk of Foot Ulceration

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: DFUPS

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • Manchester, United Kingdom, M9 4BE
    • The Pennine Acute Hospitals NHS Trust
  • Newcastle upon Tyne, United Kingdom, NE3 3HD
    • The Newcastle Upon Tyne Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18 years or older
• Has either type 1 or type 2 diabetes
• Has intact feet as defined by the absence of a skin breakdown below the malleoli.
• Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold > 25 volts on one OR both feet)
• Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months
• Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
• Has no history of peripheral arterial disease
• Has footwear which in the opinion of the investigator is not likely to cause pressure damage
• Must be able to provide meaningful written informed consent for the study

Exclusion Criteria:

• Is aged <18
• Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study.
• Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study
• Has active foot ulceration and infection
• Has active Charcot osteoarthropathy
• Has established Charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study.
• Has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study
• Has an implantable electronic device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFUPS (visual and thermal images); Visual and thermal imaging with DFUPS and standard foot care. The study investigator will have access to the thermal and visual images captured with DFUPS.	Device: DFUPS; The DFUPS device is a two-camera instrument for capturing images of feet.
Placebo Comparator: DFUPS ( visual images); Visual and blinded thermal imaging with DFUPS and standard foot care. The study investigator will have access only to the visual images and will be blinded to the thermal images which will be captured at each visit but accessed only at the end of the study.	Device: DFUPS; The DFUPS device is a two-camera instrument for capturing images of feet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients developing a foot ulcer	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to ulceration	12 months
Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L	12 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: National Institute for Health Research, United Kingdom; Pennine Acute Hospitals NHS Trust; University of South Wales; Freeman Health System; National Physical Laboratory; Photometrix
• Investigators: Principal Investigator: Michael Edmonds, MD, FRCP, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2016
• Primary Completion (Actual): September 27, 2017
• Study Completion (Actual): September 27, 2017

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: diabetic foot ulcer; Diabetic Foot; foot temperature
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: version 1 05/10/2015