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

King's College Hospital NHS Trust3 sites in 1 country110 target enrollmentFebruary 8, 2016

ConditionsDiabetic Foot

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: King's College Hospital NHS Trust
Enrollment: 110
Locations: 3
Primary Endpoint: Percentage of patients developing a foot ulcer
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2016

End Date

September 27, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College Hospital NHS Trust

Responsible Party

Sponsor

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