Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: Device: DFUPS

• Registration Number: NCT02579070
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Study Start: 2016-02-08
• Primary Completion: 2017-09-27
• Study Completion: 2017-09-27
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFUPS (visual and thermal images)	DFUPS	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.
DFUPS ( visual images)	DFUPS	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients developing a foot ulcer	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

King's College Hospital; 🇬🇧 London, United Kingdom

The Newcastle upon Tyne Hospitals; 🇬🇧 Newcastle upon Tyne, United Kingdom

The Pennine Acute Hospitals NHS Trust; 🇬🇧 Manchester, United Kingdom