Clinical Trial: Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at H
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 Summary:
Sponsor: King's College Hospital NHS Trust
Current Primary Outcome: Percentage of patients developing a foot ulcer [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to ulceration [ Time Frame: 12 months ]
- Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: King's College Hospital NHS Trust
Dates:
Date Received: October 15, 2015
Date Started: March 2016
Date Completion: September 2017
Last Updated: October 12, 2016
Last Verified: October 2016
