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RecruitingNCT07040488ETPDGUpdated Jun 27, 2025

Study of Infrared Thermography in Diabetic Foot in Guadeloupe

An observational study in Diabetic Foot Infection, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Diabetic Foot Infection

Keywords

  • Infrared thermography
  • diabetic foot
  • infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility 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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: baseline

Secondary outcomes

  1. Temperatures on the same area of the contralateral foot

    Temperatures in degrees Celsius (°C) at the level of the ulceration of the diabetic foot and on the same area of the contralateral foot

    Time frame: baseline

06

Study locations

1 of 1 sites recruiting
  • Chu de La Guadeloupe
    Pointe-à-Pitre, Guadeloupe
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07040488
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Jun 27, 2025
Start date
Sep 27, 2024
Primary completion
Mar 27, 2026 (estimated)
Completion
Mar 27, 2026 (estimated)
Last update
Jun 27, 2025

Study contacts

Mélanie petapermal
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Vanéva CHINGAN-MARTINO, MD
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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