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Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

U

University of Seville

Status

Not yet enrolling

Conditions

Diabetic Foot
Diabetic Neuropathies
Diabetic Angiopathy

Treatments

Diagnostic Test: Termography

Study type

Observational

Funder types

Other

Identifiers

NCT06485362
TERMOGRAPGY-DIABETICFOOT

Details and patient eligibility

About

Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.

Objective

To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.

Full description

Significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. It is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion.

The results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. This could allow early and personalized interventions to prevent serious complications.

Enrollment

100 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.

Exclusion criteria

Skin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.

Trial design

100 participants in 2 patient groups

healthy patients
Description:
Subjects healthy will rest barefoot for 15 minutes in a room at constant temperature (22-24°C). Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral). Images will be analyzed to identify temperature differences between different areas of the foot and between study groups.
Treatment:
Diagnostic Test: Termography
diabetic foot patients
Description:
Subjects with diabetic foot, diagnosed with diabetes mellitus for more than 5 years, will rest barefoot for 15 minutes in a room at a constant temperature (22-24°C). Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral). The images will be analyzed to identify temperature differences between different areas of the foot and between the study groups.
Treatment:
Diagnostic Test: Termography

Trial contacts and locations

1

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Central trial contact

RAQUEL GARCIA DE LA PEÑA, DOCTOR; ANA M RAYO PEREZ, DOCTOR

Data sourced from clinicaltrials.gov

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