Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

October 7, 2020 updated by: VisionQuest Biomedical LLC
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pattern of thermal recovery
Time Frame: 24 months
The thermal recovery pattern after cold provocation will be different for each group studied.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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:

  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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VisionQuest Biomedical LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of New Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Soliz, PhD, VisionQuest Biomedical LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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