Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

NCT06485362 | Not Yet Recruiting

• 1 other identifier: TERMOGRAPGY-DIABETICFOOT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Neuropathies; Diabetic Angiopathy

Keywords

diabetic foot; neuropaty; angiopaty; termography

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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

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

Interventions

Termography DIAGNOSTIC_TEST

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

diabetic foot patients; healthy patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville

Seville, 41008, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Healthy subjects will have thermographic images of both feet taken in multiple views

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies; Diabetic Angiopathies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• RAQUEL GARCIA DE LA PEÑA, DOCTOR

  University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAQUEL GARCIA DE LA PEÑA, DOCTOR

CONTACT

954486530; raquelgp@us.es

ANA M RAYO PEREZ, DOCTOR

CONTACT

661604278; anarayo43@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)