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
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.
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 191 observational studies indexed under Diabetic Foot.
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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.
Inclusion Criteria for Control Group
Inclusion Criteria for diabetic patients:
Exclusion Criteria :
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 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 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.
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
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
Plan to share: Undecided
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Centre Hospitalier Universitaire de la Guadeloupe