Study of Infrared Thermography in Diabetic Foot in Guadeloupe (ETPDG)

Centre Hospitalier Universitaire de la Guadeloupe

Status: Enrolling

Conditions: Diabetic Foot Infection

Study type: Observational

Funder types: Other

Identifiers

NCT07040488

PAP_RIPH2_2024/03

2024-A00993-44 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Control Group

• 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

Inclusion Criteria for diabetic patients:

• 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

Trial design

150 participants in 3 patient groups

non-diabetic individuals (control group)

Description:

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.

diabetic individuals with diabetic foot ulceration

Description:

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.

diabetic individuals without diabetic foot ulceration

Description:

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.