Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

Diabetic Retinopathy Clinical Trial

Official title:

Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069729
• Other study ID #: R43DK104578-01
• Status: Completed
• Start date: March 8, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2020
• Source: VisionQuest Biomedical LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Neuropathies
• Diabetic Retinopathy
• Peripheral Nervous System Diseases

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.

Locations

Country	Name	City	State
United States	VisionQuest Biomedical LLC	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
VisionQuest Biomedical LLC	University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of thermal recovery	The thermal recovery pattern after cold provocation will be different for each group studied.	24 months
Secondary	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