Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

Completed

• Conditions: Diabetic Neuropathies; Diabetic Foot; Diabetic Retinopathy
• Interventions: Other: no intervention

• Registration Number: NCT03069729
• Lead Sponsor: VisionQuest Biomedical LLC

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-03-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetics with DPN	no intervention	diabetics with DPN; no intervention
Control group	no intervention	non-diabetic; no intervention
Diabetics without DPN	no intervention	diabetics without DPN; no intervention

Primary Outcome Measures

Name	Time	Method
Pattern of thermal recovery	24 months	The thermal recovery pattern after cold provocation will be different for each group studied.

Secondary Outcome Measures

Name	Time	Method
Correlation of DPN severity levels and DR severity levels	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: 1. No apparent retinopathy; 2. Mild nonproliferative diabetic retinopathy; 3. Moderate nonproliferative diabetic retinopathy; 4. Severe nonproliferative diabetic retinopathy; 5. 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

Trial Locations

Locations (1)

VisionQuest Biomedical LLC; 🇺🇸 Albuquerque, New Mexico, United States