Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

NCT ID: NCT02798393

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-10-31

Brief 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 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.

Conditions

Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HL-Sham

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

HL-NIR

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.

Group Type: EXPERIMENTAL

Infrared Phototherapy

Intervention Type: OTHER

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).

Interventions

Infrared Phototherapy

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

Sham

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Type 2 Diabetes Mellitus on oral hypoglycemic medication, and/or injectable insulin

2. Hg A1C 5.7 or above ((Pre-Diabetes is 5.7 to 6.4%) (Diabetes is above 6.5%)), Hg A1C below 9.1

3. Peripheral Neuropathy of the feet, or feet and legs

4. 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.

5. 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

6. Positive MNS

7. 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.

8. 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).

9. Moderately positive MNS score.

Exclusion Criteria

1. Any other causes of Peripheral Neuropathy

2. Known Spinal Stenosis

3. Previous Back Injury

4. Comorbid issues of exacerbated CHF

5. Exacerbation of COPD

6. Chronic steroid use

7. Underlying connective tissue disease

8. Previous trauma or underlying fracture

9. Current injury or trauma

10. Skin ulceration

11. 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

12. Negative MNS

13. Previous amputation of a portion of the foot

15. Previous arterial bypass graft

16. Known cardiac arrhythmia

17. HG A1C above 9.1%

18. Uncontrolled fasting blood sugar, or Type 1 Diabetes.

19. If on any anti-epileptic or anti-depressant medications

20. If patient has had any change in pain or anti-inflammatory medication anytime within the past 30 days.

21. 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.)

22. Active osteomyelitis or positive for osteomyelitis within the past six months

23. Open ulceration with signs and symptoms of active infection.

24. Known Peripheral Arterial Disease (PAD)

25. Previous Lumbar surgery or Lumbar Disc intervention anytime within the past year

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clin-Assist, LLC

UNKNOWN

Sponsor Role: collaborator

Midwest Medical Research

UNKNOWN

Sponsor Role: collaborator

Healthlight, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kipp Van Camp, DO

Role: PRINCIPAL_INVESTIGATOR

Midwest Medical Research

Locations

Midwest Medical Research

Topeka, Kansas, United States

Countries

United States

Other Identifiers

NIR-001

Identifier Type: -

Identifier Source: org_study_id