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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DFUPS
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic Foot, foot temperature, diabetic foot ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital
  • The Pennine Acute Hospitals NHS Trust
  • The Newcastle upon Tyne Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DFUPS (visual and thermal images)

DFUPS ( visual images)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of patients developing a foot ulcer

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2015
Last Updated
September 13, 2019
Sponsor
King's College Hospital NHS Trust
Collaborators
Freeman Health System, Pennine Acute Hospitals NHS Trust, National Physical Laboratory, University of South Wales, Photometrix, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02579070
Brief Title
Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2016 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
Freeman Health System, Pennine Acute Hospitals NHS Trust, National Physical Laboratory, University of South Wales, Photometrix, National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetic Foot, foot temperature, diabetic foot ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DFUPS (visual and thermal images)
Arm Type
Experimental
Arm Description
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.
Arm Title
DFUPS ( visual images)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DFUPS
Intervention Description
The DFUPS device is a two-camera instrument for capturing images of feet.
Primary Outcome Measure Information:
Title
Percentage of patients developing a foot ulcer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to ulceration
Time Frame
12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Edmonds, MD, FRCP
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M9 4BE
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals
City
Newcastle upon Tyne
ZIP/Postal Code
NE3 3HD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

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