Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Foot Diabetic Neuropathies Diabetic Angiopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy patients

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.

Termography

Intervention Type DIAGNOSTIC_TEST

Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).

diabetic foot patients

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.

Termography

Intervention Type DIAGNOSTIC_TEST

Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).

Interventions

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Termography

Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes