Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

Diabetic Foot Clinical Trial

— DFUPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579070
• Other study ID #: version 1 05/10/2015
• Status: Completed
• Phase: N/A
• Start date: February 8, 2016
• Est. completion date: September 27, 2017

Study information

• Verified date: September 2019
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Intervention

Device:
• DFUPS
The DFUPS device is a two-camera instrument for capturing images of feet.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United Kingdom	The Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	The Newcastle upon Tyne Hospitals	Newcastle upon Tyne

Sponsors (7)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Freeman Health System, National Institute for Health Research, United Kingdom, National Physical Laboratory, Pennine Acute Hospitals NHS Trust, Photometrix, University of South Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients developing a foot ulcer		12 months
Secondary	Time to ulceration		12 months
Secondary	Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L		12 months