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Completed

NCT Number: NCT03069729

Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

The goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN). The team of investigators will also look at diabetic eye disease and how it might relate to diabetic foot disease.

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Key information

Conditions

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

Age range

35 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VisionQuest Biomedical LLC

Albuquerque, New Mexico, 87106, United States

About this study

This study focuses on further development and testing of a microvascular functional imaging system, a computer-based system for screening thermal video images, designed to detect biomarkers of diabetic peripheral neuropathy (DPN). Additionally, severity levels of diabetic retinopathy (DR) will be compared with those of DPN.

All participants in this study will undergo foot exams, thermal imaging of the foot, and standard retinal imaging. These non-invasive assessments will be performed at an initial study visit. Some of the participants will be offered additional study visits. One of the additional visits involves a standard nerve conduction velocity assessment by a neurologist, the other involves a DPN exam by a podiatrist.

Portions of the study take place at University of New Mexico Health Sciences Center (UNM HSC). The research utilizes services of the Clinical Translational Science Center (CTSC).

The study is approved by University of New Mexico Health Sciences Center's Human Research Review Committee (HRRC), which coordinates and supports the activities of the three federally mandated Human Research Review Committees (HRRCs) responsible for reviewing and approving all human research.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be non-diabetic or diagnosed as diabetic for at least 5 years

Exclusion criteria

history of chemotherapy

  • surgery below the knee within the last 2 years
  • fractures below the know within the last 2 years
  • history of stroke
  • body mass index (BMI) greater than 35
  • history of heart failure
  • peacemaker or implantable cardiovascular defibrillator
  • high blood pressure (over 180/100)
  • end-stage renal (kidney) disease or renal (kidney) transplant
  • peripheral edema greater than 2+ (swelling of the feet or hands)
  • diabetic foot ulcers
  • foot sores
  • Raynaud's phenomenon
  • tobacco use within the last month.
  • treatment with glucocorticoids, including:
  • beclomethasone
  • betamethasone
  • budesonide
  • cortisone
  • dexamethasone
  • hydrocortisone
  • methylprednisolone
  • prednisolone
  • prednisone
  • triamcinolone

Treatment and study plan

No intervention

Other

This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.

Primary outcomes

  1. Pattern of thermal recovery

    Time frame: 24 months

    The thermal recovery pattern after cold provocation will be different for each group studied.

Secondary outcomes

  1. Correlation of DPN severity levels and DR severity levels

    Time frame: 18 months

    Correlation between severity levels of DR and DPN will be determined.

    The severity level of DR will be assessed by qualified retinal image readers. Level of severity will be assigned, based on the International Clinical Diabetic Retinopathy Disease Severity Scale, into 5 levels:

    • No apparent retinopathy
    • Mild nonproliferative diabetic retinopathy
    • Moderate nonproliferative diabetic retinopathy
    • Severe nonproliferative diabetic retinopathy
    • Proliferative diabetic retinopathy

    The severity of DPN will be graded by utilizing data from assessments from a DPN exam performed by an experienced podiatrist, Nerve Conduction Velocity (NCV) test performed by a neurologist, and assessments performed by technicians. Data utilized will include:

    • NVC results
    • Vibration threshold, reported in seconds
    • Monofilament test of protective sensation

Sponsors and collaborators

Lead sponsor

VisionQuest Biomedical LLC

Industry

Collaborators

  • University of New Mexico

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Oct 12, 2020

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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