Study of Infrared Thermography in Diabetic Foot in Guadeloupe

NCT ID: NCT07040488

Last Updated: 2025-06-27

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

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-27

Study Completion Date

2026-03-27

Brief Summary

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It is hypothesized that thermal imaging differs between diabetic and non-diabetic individuals in Guadeloupe. Infrared thermography is also suggested as a useful tool for studying diabetic foot ulceration. The main objective is to compare the temperatures of four areas of the plantar surface of the foot among non-diabetic individuals, diabetic individuals, and diabetic individuals with foot ulceration.

Detailed Description

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Diabetes represents a major public health issue in the region. Among its most severe complications is diabetic foot ulceration, which frequently results in amputation. Infrared thermography is a non-invasive and non-ionizing imaging technique that provides precise temperature data at specific points on the body. When combined with 3D imaging technologies, infrared thermography may offer early diagnostic potential for infections related to diabetic foot ulcers, by revealing both visible and subclinical signs. A preliminary step in assessing the relevance of thermal imaging is to determine whether thermographic patterns differ between the feet of diabetic and non-diabetic individuals within the Guadeloupean population, particularly in a tropical climate. Currently, international guidelines do not recommend infrared thermography as part of routine clinical practice for managing diabetic foot ulceration. However, this imaging modality could potentially contribute to the diagnostic arsenal for infections associated with diabetic foot ulcers.

Conditions

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Diabetic Foot Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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non-diabetic individuals (control group)

Healthy volunteers will be recruited from the post-emergency consultation service of the ambulatory medicine platform at CHUG. These are patients attending for a follow-up evaluation after a previous visit to the emergency department.

No interventions assigned to this group

diabetic individuals with diabetic foot ulceration

Diabetic patients with foot ulceration will be recruited during their visits to the multidisciplinary consultation at the Diabetic Foot Unit of the University Hospital of Guadeloupe, or during their hospitalizations in the orthopedic surgery department.

No interventions assigned to this group

diabetic individuals without diabetic foot ulceration

Diabetic patients without foot ulceration will be recruited from the diabetes day hospital at CHUG, the ambulatory medicine platform at CHUG, and the diabetes therapeutic education program.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* Patients of Afro-Caribbean origin
* Volunteer patients free from pathology
* Person affiliated to or beneficiary of a social security scheme.
* Person who has agreed to sign a consent to participate in the study


* Adult patients
* Patients of Afro-Caribbean origin
* Type 1 or type 2 diabetic patients with and without diabetic foot ulceration
* Person affiliated to or beneficiary of a social security system.
* Person who has agreed to sign a consent to participate in the study

Exclusion Criteria

* \- Minors
* patient with an active fracture or a history of fracture
* a history of legs surgery
* History of amputation
* Bilateral diabetic ulceration
* neurological disease (Parkinson, stroke, etc.)
* pregnancy
* Foot mycosis
* refusal of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanéva CHINGAN-MARTINO, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Guadeloupe

Locations

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Chu de La Guadeloupe

Pointe-à-Pitre, , Guadeloupe

Site Status RECRUITING

Countries

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Guadeloupe

Central Contacts

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Mélanie petapermal

Role: CONTACT

+590590934667

Facility Contacts

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Vaneva Chingan-Martino, MD

Role: primary

Other Identifiers

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2024-A00993-44

Identifier Type: OTHER

Identifier Source: secondary_id

PAP_RIPH2_2024/03

Identifier Type: -

Identifier Source: org_study_id

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