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Recruiting NCT07040488

Study of Infrared Thermography in Diabetic Foot in Guadeloupe

Observational Diabetic Foot Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetic Foot Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Guadeloupe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Primary outcome measures

  • temperatures at four areas of the plantar surface of the foot [Time frame: baseline]
Secondary outcome measures (1)
  • Temperatures on the same area of the contralateral foot [Time frame: baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Guadeloupe · 1 center
  • Chu de La Guadeloupe — Pointe-à-Pitre

Identifiers

NCT: NCT07040488 · PAP_RIPH2_2024/03 · 2024-A00993-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗