Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

NCT02798393 | Terminated

• 1 other identifier: NIR-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (1)

• Decrease in Pain (MPI Pain Scale)

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

  90 Days

Secondary Outcomes (1)

• Improvement in Sensation

  90 Days

Other Outcomes (1)

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

  90 Days

Study Arms (2)

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.

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.

Other: Infrared Phototherapy

Interventions

Infrared Phototherapy 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).

HL-NIR

Sham OTHER

HL-Sham

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Previous arterial bypass graft
• Known cardiac arrhythmia

Sponsors & Collaborators

• Healthlight, LLC: lead
• Clin-Assist, LLC: collaborator
• Midwest Medical Research: collaborator

Study Sites (1)

Midwest Medical Research

Topeka, Kansas, 66604, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Kipp Van Camp, DO

  Midwest Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)