Clinical trial NCT02579070: Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Diabetic Foot
foot temperature
diabetic foot ulcer
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Freeman Health System
name: Pennine Acute Hospitals NHS Trust
name: National Physical Laboratory
name: University of South Wales
name: Photometrix
name: National Institute for Health Research, United Kingdom
First posted: 2015-10-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients developing a foot ulcer
timeFrame: 12 months
Secondary outcomes:
measure: Time to ulceration
timeFrame: 12 months
measure: Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals
Study officials:
affiliation: King's College Hospital NHS Trust
name: Michael Edmonds, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: