NCT02579070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

February 8, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

October 15, 2015

Last Update Submit

September 13, 2019

Conditions

Diabetic Foot

Keywords

Diabetic Footfoot temperaturediabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients developing a foot ulcer

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

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

DFUPSDEVICE

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

DFUPS ( visual images)DFUPS (visual and thermal images)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

The Pennine Acute Hospitals NHS Trust

Manchester, M9 4BE, United Kingdom

Location

The Newcastle upon Tyne Hospitals

Newcastle upon Tyne, NE3 3HD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Michael Edmonds, MD, FRCP

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 19, 2015

Study Start

February 8, 2016

Primary Completion

September 27, 2017

Study Completion

September 27, 2017

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

GB(3)