Diabetic NeuropathiesNCT03069729
Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
An observational study of Diabetic Neuropathies and Diabetic Foot, run by VisionQuest Biomedical LLC at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 35 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathies, Diabetic Foot, Diabetic Retinopathy
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.
Who may be able to join
- Must be non-diabetic or diagnosed as diabetic for at least 5 years
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VisionQuest Biomedical LLC
Albuquerque, New Mexico, 87106
About this study
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.
Read the 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
- Being tested
- no intervention
- Keywords
- screen
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
| Study group | Role | What they receive |
|---|---|---|
| Control group | non-diabetic; no intervention Receives: Other: no intervention | |
| Diabetics without DPN | diabetics without DPN; no intervention Receives: Other: no intervention | |
| Diabetics with DPN | diabetics with DPN; no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of thermal recovery
The thermal recovery pattern after cold provocation will be different for each group studied.
Measured: 24 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start8 Mar 2017
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionQuest Biomedical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico
- Responsible party
- Sponsor
- Investigators
- Peter Soliz, PhD, Principal investigator, VisionQuest Biomedical LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069729
- Sponsor's protocol ID
- R43DK104578-01
- Status last verified
- Oct 2020
- First submitted
- 16 Feb 2017
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
- ClinicalTrials.gov ID
- NCT03069729
- Acronym / sponsor ID
- R43DK104578-01
- Conditions
- Diabetic Neuropathies, Diabetic Foot, Diabetic Retinopathy
- Keywords
- screen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- VisionQuest Biomedical LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of New Mexico
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: no interventionnon-diabetic; no intervention |
| Diabetics without DPN | – | Other: no interventiondiabetics without DPN; no intervention |
| Diabetics with DPN | – | Other: no interventiondiabetics with DPN; no intervention |
Who may qualify
- Ages
- 35 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of diabetic and non-diabetic individuals who are otherwise healthy.
Key inclusion criteria (1 listed)
- Must be non-diabetic or diagnosed as diabetic for at least 5 years
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study. | Other | Control group, Diabetics with DPN, Diabetics without DPN |
Primary outcome
Pattern of thermal recovery
Time frame: 24 months
The thermal recovery pattern after cold provocation will be different for each group studied.
1 secondary outcome
Correlation of DPN severity levels and DR severity levels
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Soliz, PhD principal investigator
VisionQuest Biomedical LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathies and Diabetic Foot, run by VisionQuest Biomedical LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of thermal recovery (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.