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NCT Number: NCT06485362

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Angiopathy Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Termography

Diagnostic Test

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

Primary outcomes

  1. Temperature maximun

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

    Maximum foot temperatures

  2. Temperature minimum

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

    Minimum foot temperatures

Study contacts

Contact information is provided by the study sponsor or research team.

ANA M RAYO PEREZ, DOCTOR

CONTACT

[email protected]

661604278 ext. +34

RAQUEL GARCIA DE LA PEÑA, DOCTOR

CONTACT

[email protected]

954486530 ext. +34

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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