Study of Infrared Thermography in Diabetic Foot in Guadeloupe

NCT07040488 | Recruiting

• 2 other identifiers: PAP_RIPH2_2024/032024-A00993-44
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Infection

Keywords

Infrared thermography; diabetic foot; infection

Outcome Measures

Primary Outcomes (1)

• temperatures at four areas of the plantar surface of the foot

  The primary outcome is the measurement of temperatures in degrees Celsius (°C) using infrared thermography (coupled with a 3D camera) at four areas of the plantar surface of the foot: the pulp of the hallux, the heel, the heads of the first and fifth metatarsals, and at the site of the diabetic foot ulcer.

  baseline

Secondary Outcomes (1)

• Temperatures on the same area of the contralateral foot

  baseline

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 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. Diabetic patients with diabetic 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. Based on data from previous years, the active patient list consulting the Diabetic Foot Unit (UPPD) for foot ulceration is estimated to exceed 300 individuals.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, Guadeloupe

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Vanéva CHINGAN-MARTINO, MD

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie petapermal

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: September 27, 2024
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

GU (1)