NCT02798393

Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Healthlight, LLC · Industry
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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).
OTHER	Sham

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-06-14
• Last updated: 2017-03-01

Locations

1 site across 1 country: United States