Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

331 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetic Neuropathies Diabetic Foot Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

non-diabetic; no intervention

no intervention

Intervention Type OTHER

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

no intervention

Intervention Type OTHER

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

no intervention

Intervention Type OTHER

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

Interventions

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no intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes