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Transient Thermal Behavior and Diabetic Foot

NCT ID: NCT03872089

Last Updated: 2021-12-30

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

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-04-08

Brief Summary

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In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.

Detailed Description

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Both plants of the patient's feet will be observed by a thermal camera. Static observations (taking a single image), or dynamic (taking a series of images) of the foot, will be made. In the latter case, the observation will be done after a brisk walk of 6 min. The instruction given to patients will be to go the furthest in 3 min and then come back in 3 min, all while walking. The observation will be made by cameras without contact. These thermal cameras are non-invasive and non-ionizing, there is no risk related to their use. The camera will be placed on a tripod, a few tens of centimeters from the foot, and connected to a laptop (for the images acquisition). A wooden box, painted black, will be placed around both feet to protect the scene from parasitic thermal radiation that can disturb temperature variations. Foam will protect the skin / wood interface. Electric resistances, fixed on the box, will be placed in the field of vision of the thermal camera to guarantee the good treatment of the images. These resistors will never be in contact with the patient. The area filmed by the camera will be limited to the sole arch and, sometimes, the hand of patients to see if a thermal anomaly is also present on this member.

Conditions

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Diabetic Patients Type 1 and 2 Podologic Grade From 0 to 3

Keywords

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Infrared Thermography Diabetic foot Six minutes walking test Microcirculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study participants

Measurements of the temperature of the plantar arch by thermal imaging. Result analysis regarding podologic grade ( 0-1-2-3)

Group Type EXPERIMENTAL

Infrared Thermography

Intervention Type OTHER

Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)

Interventions

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Infrared Thermography

Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diabetic subjects (type 1 and 2)
* age above 18 years old
* able to walk
* affiliate to insurance regimen

Exclusion Criteria

* unable to stay motionless
* pregnancy
* subjects with feet wound
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Montpellier

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ariane Sultan, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier

Locations

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CHU Montpellier - Lapeyronie hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0371

Identifier Type: -

Identifier Source: org_study_id