Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot; Diabetic Neuropathies; Diabetic Angiopathy
• Intervention / Treatment: Diagnostic test: Termography

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: RAQUEL GARCIA DE LA PEÑA, DOCTOR; Phone Number: +34 954486530; Email: raquelgp@us.es
• Study Contact Backup: Name: ANA M RAYO PÉREZ, DOCTOR; Phone Number: +34 661604278; Email: anarayo43@gmail.com

Study Locations

• Spain
  • Seville, Spain, 41008
    • University of Seville
    • Contact: RAQUEL GARCIA DE LA PEÑA, DOCTOR; Phone Number: +34 954486530; Email: raquelgp@us.es
    • Contact: ANA M RAYO PÉREZ, DOCTOR; Phone Number: +34 661604278; Email: anarayo43@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects or those with type 2 diabetes mellitus for more than 5 years who wish to participate in the study voluntarily, who will undergo a thermography of both feet.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Termography; 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.	Diagnostic test: Termography; Thermographic images of both feet will be taken in multiple views (dorsal, plantar, lateral).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature maximun	Maximum foot temperatures	One measurement will be taken at the start of the study and another measurement the following year.
Temperature minimum	Minimum foot temperatures	One measurement will be taken at the start of the study and another measurement the following year.

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: RAQUEL GARCIA DE LA PEÑA, DOCTOR, University of Seville

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: diabetic foot; neuropaty; angiopaty; termography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Endocrine System Diseases; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Foot Ulcer; Diabetic Foot; Diabetic Neuropathies; Diabetic Angiopathies
• Other Study ID Numbers: TERMOGRAPGY-DIABETICFOOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No