Diabetic Foot InfectionETPDGNCT07040488
Study of Infrared Thermography in Diabetic Foot in Guadeloupe
An observational study of Diabetic Foot Infection, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Infection
- How many people
- 150 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 27 Sep 2024to 27 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- - 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.)
Show all 9Show fewer
- pregnancy
- Foot mycosis
- refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
Chu de La Guadeloupe
Pointe-à-Pitre
Vaneva Chingan-Martino, MD, vaneva.chingan@chu-guadeloupe.fr
Vanéva CHINGAN-MARTINO, MD
About this study
Official title: Study of Infrared Thermography in Diabetic Foot in Guadeloupe (ETPDG)
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.
- Conditions
- Diabetic Foot Infection
- Keywords
- Infrared thermography, diabetic foot, infection
- Medical subject headings
- Diabetic Foot, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start27 Sep 2024
- Primary completion27 Mar 2026 (estimated)
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanéva CHINGAN-MARTINO, MD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040488
- Sponsor's protocol ID
- PAP_RIPH2_2024/03
- Other IDs
- 2024-A00993-44
- Acronym
- ETPDG
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Infrared Thermography in Diabetic Foot in Guadeloupe (ETPDG)
- ClinicalTrials.gov ID
- NCT07040488
- Acronym / sponsor ID
- ETPDG / PAP_RIPH2_2024/03
- Conditions
- Diabetic Foot Infection
- Keywords
- Infrared thermography, diabetic foot, infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 27 Mar 2026 (estimated)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- - Minors
- patient with an active fracture or a history of fracture
- a history of legs surgery
- History of amputation
- Bilateral diabetic ulceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
temperatures at four areas of the plantar surface of the foot
Time frame: baseline
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.
1 secondary outcome
Temperatures on the same area of the contralateral foot
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanéva CHINGAN-MARTINO, MD principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Infection, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie petapermal (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperatures at four areas of the plantar surface of the foot (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.