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Clinical Trials/NCT06485362
NCT06485362
Not Yet Recruiting
N/A

Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

University of Seville1 site in 1 country100 target enrollmentSeptember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
University of Seville
Enrollment
100
Locations
1
Primary Endpoint
Temperature minimum
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ANA MARIA RAYO PEREZ

Principal Investigator

University of Seville

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Temperature minimum

Time Frame: One measurement will be taken at the start of the study and another measurement the following year.

Minimum foot temperatures

Temperature maximun

Time Frame: One measurement will be taken at the start of the study and another measurement the following year.

Maximum foot temperatures

Study Sites (1)

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