Diabetic Foot Ulcer Prevention System

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

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-04-30

Brief Summary

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To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.

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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

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Study in healthy volunteers

Skin foot temperature measurement by DFUPS device

Group Type OTHER

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

1. Aged 18 years or older
2. Has no history of diabetes
3. Has no previous history of foot ulceration
4. Has no previous history of foot surgery
5. Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
6. Has no history of peripheral neuropathy
7. Has no history of peripheral arterial disease
8. Must be able to provide meaningful written informed consent for the study

Exclusion Criteria

1. Has active foot ulceration and infection
2. Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
3. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
4. Has an implantable electronic device
5. Is aged \<18

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes