Clinical trial NCT03069729: Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
Official title: Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathies
Diabetic Foot
Diabetic Retinopathy
Keywords: screen
Lead sponsor: VisionQuest Biomedical LLC
Sponsor class: INDUSTRY
Collaborators: name: University of New Mexico
First posted: 2017-03-03
Enrollment: 331
Sex: ALL
Minimum age (years): 35
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pattern of thermal recovery
timeFrame: 24 months
Secondary outcomes:
measure: Correlation of DPN severity levels and DR severity levels
timeFrame: 18 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: VisionQuest Biomedical LLC
state: New Mexico
Study officials:
affiliation: VisionQuest Biomedical LLC
name: Peter Soliz, PhD
role: PRINCIPAL_INVESTIGATOR
References: