Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

Not yet recruiting

• Conditions: Diabetic Angiopathy; Diabetic Foot; Diabetic Neuropathies
• Interventions: Diagnostic Test: Termography

• Registration Number: NCT06485362
• Lead Sponsor: University of Seville

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Start: 2024-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy patients	Termography	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.
diabetic foot patients	Termography	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.

Primary Outcome Measures

Name	Time	Method
Temperature maximun	One measurement will be taken at the start of the study and another measurement the following year.	Maximum foot temperatures
Temperature minimum	One measurement will be taken at the start of the study and another measurement the following year.	Minimum foot temperatures

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Seville, Spain