NeuropathyResearchNIRNCT02798393
Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy
A study testing Infrared Phototherapy in people with Neuropathy, run by Healthlight, LLC at 1 site in United States.
Trial summary
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to… Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Neuropathy
- What is being tested?
- Infrared Phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Oct 2016
- Phase
- Interventional
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin
- Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1
- Peripheral Neuropathy of the feet, or feet and legs
- If the patient has a lower extremity ulceration that is not showing any signs of infection, and this patient has ABPI and TBPI above 55 mm of Hg, they may be included in the study, at the discretion of the Principal Investigator (PI). If the patients infection is localized (not osseous in nature) and the infection can be treated and cleared and remain uninfected for 30 days, the patient could be reevaluated and included in the study at the discretion of the PI.
- If the patient has an area of injury or erythema or induration, they may still be included in the study if they have ABPI and TBPI above 55 mm of Hg, at the discretion of the PI
- Positive MNS
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- All medications or other treatments for neuropathy are held constant for at least 30 days prior to the study, during the baseline and treatment period of the study.
- Subjects will have pain and insensate sites on each foot (both feet will be assessed and pain scales for both extremities will be measured/followed).
- Moderately positive MNS score.
Who cannot join
- Any other causes of Peripheral Neuropathy
- Known Spinal Stenosis
- Previous Back Injury
- Comorbid issues of exacerbated CHF
- Exacerbation of COPD
- Chronic steroid use
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- Underlying connective tissue disease
- Previous trauma or underlying fracture
- Current injury or trauma
- Skin ulceration
- ABPI and TBPI measurements will be measured and if the patient has an open ulceration with signs of infection and the wound is weeping any serous or purulent fluid, anywhere on their foot or lower extremity
- Negative MNS
- Previous amputation of a portion of the foot
- Amputation of digit or digits are not considered exclusion criteria
- Previous arterial bypass graft
- Known cardiac arrhythmia
- HG A1C above 9.1%
- Uncontrolled fasting blood sugar, or Type 1 Diabetes.
- If on any anti-epileptic or anti-depressant medications
- If patient has had any change in pain or anti-inflammatory medication anytime within the past 30 days.
- Pregnancy or planned pregnancy (If a patient has begun our research study and does not know that they are pregnant or they become pregnant during the study, they will not be dropped from the study) (Reasoning: there is no evidence for or against using HealthLight therapy in pregnant individuals.)
- Active osteomyelitis or positive for osteomyelitis within the past six months
- Open ulceration with signs and symptoms of active infection.
- Known Peripheral Arterial Disease (PAD)
- Previous Lumbar surgery or Lumbar Disc intervention anytime within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Study of the Efficacy of Near Infrared Phototherapy on Sensation and Pain in Type 2 Diabetic Neuropathy
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.
Read the detailed description
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.
Randomization and Application of HL Device The placebo controlled group of 60 patients will be randomized from the group of 120 patients by one designee who selects the placebo vs treatment groups based on acceptable statistical standards for determining placebo vs treatment arms of research studies. There will be two different HL Devices. There will be the HL-NIR device that includes NIR diodes and performs Near Infrared therapy and an identical appearing second device, the HL-SHAM device, that is used as the placebo device and although appearance is identical, this device does not perform Near Infrared treatment. Both placebo group and treatment group subjects will have the NIR or sham device applied to both lower extremities for a short duration three times a week over the course of several weeks.
- Conditions
- Neuropathy
- Being tested
- Infrared Phototherapy, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared PhototherapyOther
Subjects will wear a cuff on their extremities for a set period of time at set intervals over a period of several weeks. The cuff will emit the Infrared Phototherapy treatment (or sham if randomized to the non-treat group).
ShamOther
| Study group | Role | What they receive |
|---|---|---|
| HL-Sham | Sham comparator | The placebo device (also referred to as the HL-SHAM device) will have an identical appearance to the HL-NIR device. Though the HL-NIR device will be applied, there will be no treatment administered. Receives: Other: Sham |
| HL-NIR | Experimental | The device referred to as the HL-NIR device includes both a podiatric or foot and leg component, similar to a loose fitting boot, that is easily applied to all subjects (one size fits all). Application of the device is snug but comfortable without risk for constriction of soft tissue. Receives: Other: Infrared Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Pain (MPI Pain Scale)
Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale
Measured: 90 Days
Secondary outcomes (1)
Improvement in Sensation
Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Study blind compromised.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthlight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Assist, LLC, Midwest Medical Research
- Responsible party
- Sponsor
- Investigators
- Kipp Van Camp, DO, Principal investigator, Midwest Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798393
- Sponsor's protocol ID
- NIR-001
- Acronym
- ResearchNIR
- Status last verified
- Feb 2017
- First submitted
- 4 Jun 2016
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Study of the Efficacy of Near Infrared Phototherapy on Sensation and Pain in Type 2 Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02798393
- Acronym / sponsor ID
- ResearchNIR / NIR-001
- Conditions
- Neuropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study blind compromised.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Healthlight, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Assist, LLC, Midwest Medical Research
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.
Detailed description
This is a double blind, randomized, placebo-controlled study in which a total of 120 patients will be selected from a broad spectrum group of typical Americans (all demographics including various races and both genders as well as ages from 25-90) who have confirmed Type 2 Diabetes Mellitus and suffer from mild to moderate lower extremity Peripheral Neuropathy. All patients will meet inclusion and/or exclusion criteria.
Randomization and Application of HL Device The placebo controlled group of 60 patients will be randomized from the group of 120 patients by one designee who selects the placebo vs treatment groups based on acceptable statistical standards for determining placebo vs treatment arms of research studies. There will be two different HL Devices. There will be the HL-NIR device that includes NIR diodes and performs Near Infrared therapy and an identical appearing second device, the HL-SHAM device, that is used as the placebo device and although appearance is identical, this device does not perform Near Infrared treatment. Both placebo group and treatment group subjects will have the NIR or sham device applied to both lower extremities for a short duration three times a week over the course of several weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL-Sham | Sham comparator | Other: ShamThe placebo device (also referred to as the HL-SHAM device) will have an identical appearance to the HL-NIR device. Though the HL-NIR device will be applied, there will be no treatment administered. |
| HL-NIR | Experimental | Other: Infrared PhototherapyThe device referred to as the HL-NIR device includes both a podiatric or foot and leg component, similar to a loose fitting boot, that is easily applied to all subjects (one size fits all). Application of the device is snug but comfortable without risk for constriction of soft tissue. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin
- Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1
- Peripheral Neuropathy of the feet, or feet and legs
- If the patient has a lower extremity ulceration that is not showing any signs of infection, and this patient has ABPI and TBPI above 55 mm of Hg, they may be included in the study, at the discretion of the Principal Investigator (PI). If the patients infection is localized (not osseous in nature) and the infection can be treated and cleared and remain uninfected for 30 days, the patient could be reevaluated and included in the study at the discretion of the PI.
- If the patient has an area of injury or erythema or induration, they may still be included in the study if they have ABPI and TBPI above 55 mm of Hg, at the discretion of the PI
Key exclusion criteria (25 listed)
- Any other causes of Peripheral Neuropathy
- Known Spinal Stenosis
- Previous Back Injury
- Comorbid issues of exacerbated CHF
- Exacerbation of COPD
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 |
|---|---|---|
| Infrared PhototherapySubjects will wear a cuff on their extremities for a set period of time at set intervals over a period of several weeks. The cuff will emit the Infrared Phototherapy treatment (or sham if randomized to the non-treat group). | Other | HL-NIR |
| Sham | Other | HL-Sham |
Primary outcome
Decrease in Pain (MPI Pain Scale)
Time frame: 90 Days
Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale
1 secondary outcome
Improvement in Sensation
Time frame: 90 Days
Results and safety
The study was stopped early (reason given: Study blind compromised.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- 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.
Kipp Van Camp, DO principal investigator
Midwest Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared Phototherapy in people with Neuropathy, run by Healthlight, 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 9 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: stopped early, as of the sponsor's last update on 1 Mar 2017. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study blind compromised.). Results are not available in the source record.
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?
Decrease in Pain (MPI Pain Scale) (time frame: 90 Days). 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 1 Mar 2017.