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Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy (ResearchNIR)

Primary Purpose

Neuropathy

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Infrared Phototherapy

Sham

About this trial

This is an interventional treatment trial for Neuropathy

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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.

Exclusion Criteria:

Any other causes of Peripheral Neuropathy
Known Spinal Stenosis
Previous Back Injury
Comorbid issues of exacerbated CHF
Exacerbation of COPD
Chronic steroid use
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

Sites / Locations

Midwest Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

HL-Sham

HL-NIR

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Decrease in Pain (MPI Pain Scale)

Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale

Secondary Outcome Measures

Improvement in Sensation

Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring

Full Information

NCT ID

NCT02798393

First Posted

June 4, 2016

Last Updated

February 27, 2017

Sponsor

Healthlight, LLC

Collaborators

Clin-Assist, LLC, Midwest Medical Research

1. Study Identification

Unique Protocol Identification Number

NCT02798393

Brief Title

Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

Acronym

ResearchNIR

Official Title

Randomized Double-Blind Study of the Efficacy of Near Infrared Phototherapy on Sensation and Pain in Type 2 Diabetic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Study blind compromised.

Study Start Date

June 2016 (Actual)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Healthlight, LLC

Collaborators

Clin-Assist, LLC, Midwest Medical Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HL-Sham

Arm Type

Sham Comparator

Arm Description

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.

Arm Title

HL-NIR

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Infrared Phototherapy

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Sham

Primary Outcome Measure Information:

Title

Decrease in Pain (MPI Pain Scale)

Description

Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale

Time Frame

90 Days

Secondary Outcome Measure Information:

Title

Improvement in Sensation

Description

Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring

Time Frame

90 Days

Other Pre-specified Outcome Measures:

Title

Safety Assessment (incidence of treatment related AEs at each follow up visit)

Description

Incidence of treatment related adverse events at each follow up visit

Time Frame

90 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Exclusion Criteria: Any other causes of Peripheral Neuropathy Known Spinal Stenosis Previous Back Injury Comorbid issues of exacerbated CHF Exacerbation of COPD Chronic steroid use 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kipp Van Camp, DO

Organizational Affiliation

Midwest Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Midwest Medical Research

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66604

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

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