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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Neuropathies; Diabetic Retinopathy
• Intervention / Treatment: Other: no intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 331

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • VisionQuest Biomedical LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; non-diabetic; no intervention	Other: no intervention; This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
Diabetics without DPN; diabetics without DPN; no intervention	Other: no intervention; This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
Diabetics with DPN; diabetics with DPN; no intervention	Other: no intervention; This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of thermal recovery	The thermal recovery pattern after cold provocation will be different for each group studied.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of DPN severity levels and DR severity levels	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	18 months

Collaborators and Investigators

• Sponsor: VisionQuest Biomedical LLC
• Collaborators: University of New Mexico
• Investigators: Principal Investigator: Peter Soliz, PhD, VisionQuest Biomedical LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: screen
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Neuromuscular Diseases; Foot Ulcer; Diabetic Foot; Diabetic Retinopathy; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: R43DK104578-01 (U.S. NIH Grant/Contract)

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