Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
1 other identifier
observational
331
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 12, 2020
October 1, 2020
2.4 years
February 16, 2017
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pattern of thermal recovery
The thermal recovery pattern after cold provocation will be different for each group studied.
24 months
Secondary Outcomes (1)
Correlation of DPN severity levels and DR severity levels
18 months
Study Arms (3)
Control group
non-diabetic; no intervention
Diabetics without DPN
diabetics without DPN; no intervention
Diabetics with DPN
diabetics with DPN; no intervention
Interventions
This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
Eligibility Criteria
The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.
You may qualify if:
- Must be non-diabetic or diagnosed as diabetic for at least 5 years
You may not qualify if:
- 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:
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VisionQuest Biomedical LLClead
- University of New Mexicocollaborator
Study Sites (1)
VisionQuest Biomedical LLC
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Soliz, PhD
VisionQuest Biomedical LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
March 3, 2017
Study Start
March 8, 2017
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
October 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share