NCT03069729

Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 331 (actual)
• Sponsor: VisionQuest Biomedical LLC · Industry
• Sex: All
• Age: 35 Years – 76 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Neuropathies
• Diabetic Foot
• Diabetic Retinopathy

Interventions

Type	Name	Description
OTHER	no intervention	This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.

Timeline

• Start date: 2017-03-08
• Primary completion: 2019-08-01
• Completion: 2019-09-01
• First posted: 2017-03-03
• Last updated: 2020-10-12

Locations

1 site across 1 country: United States