Diabetic Foot Ulcer Prevention System (DFUPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-08

Study Completion Date

2017-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DFUPS (visual and thermal images)

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.

Group Type EXPERIMENTAL

DFUPS

Intervention Type DEVICE

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

DFUPS ( visual images)

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.

Group Type PLACEBO_COMPARATOR

DFUPS

Intervention Type DEVICE

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

Interventions

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DFUPS

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No