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Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03069729
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : September 18, 2017
University of New Mexico
Information provided by (Responsible Party):
VisionQuest Biomedical LLC

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.

Condition or disease Intervention/treatment
Diabetic Neuropathies Diabetic Foot Diabetic Retinopathy Other: no intervention

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.

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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Control group
non-diabetic; no 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.

Diabetics without DPN
diabetics without DPN; no 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.

Diabetics with DPN
diabetics with DPN; no 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.

Primary Outcome Measures :
  1. Pattern of thermal recovery [ Time Frame: 24 months ]
    The thermal recovery pattern after cold provocation will be different for each group studied.

Secondary Outcome Measures :
  1. Correlation of DPN severity levels and DR severity levels [ Time Frame: 18 months ]

    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:

    1. No apparent retinopathy
    2. Mild nonproliferative diabetic retinopathy
    3. Moderate nonproliferative diabetic retinopathy
    4. Severe nonproliferative diabetic retinopathy
    5. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03069729

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Contact: Maria Vahtel, MA 505-508-1984 ext 1015

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United States, New Mexico
VisionQuest Biomedical LLC Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Maria Vahtel, MA    505-508-1994 ext 1015   
Contact: Niranchana Manivannan, PhD    505-505-1994 ext 1019   
Principal Investigator: Peter Soliz, PhD         
Principal Investigator: Mark Burge, MD         
Sponsors and Collaborators
VisionQuest Biomedical LLC
University of New Mexico
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Principal Investigator: Peter Soliz, PhD VisionQuest Biomedical LLC

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Responsible Party: VisionQuest Biomedical LLC Identifier: NCT03069729     History of Changes
Other Study ID Numbers: R43DK104578-01 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VisionQuest Biomedical LLC:

Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Retinopathy
Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Neuromuscular Diseases
Nervous System Diseases