Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2 | NCT02579070

Studies
Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

NCT02579070

Sponsor

King's College Hospital NHS Trust

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

DFUPS

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2016Actual

Primary Completion Date

Sep 27, 2017Actual

Completion Date

Sep 27, 2017Actual

First Submitted Date

Oct 15, 2015

First Submission Date that Met QC Criteria

Oct 16, 2015

First Posted Date

Oct 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2019

Last Update Posted Date

Sep 17, 2019Actual

Name	Class
Freeman Health System	OTHER
Pennine Acute Hospitals NHS Trust	OTHER
National Physical Laboratory	OTHER
University of South Wales

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DFUPS (visual and thermal images)	Experimental	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.	Device: DFUPS
DFUPS ( visual images)	Placebo Comparator	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.	Device: DFUPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DFUPS	Device	The DFUPS device is a two-camera instrument for capturing images of feet.	DFUPS ( visual images) DFUPS (visual and thermal images)

Measure	Description	Time Frame
Percentage of patients developing a foot ulcer		12 months

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
King's College Hospital		London		SE5 9RS	United Kingdom
The Pennine Acute Hospitals NHS Trust

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer