Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 1:48 AM
Study NCT ID:
NCT02798393
Status:
TERMINATED
Last Update Posted:
2017-03-01
First Post:
2016-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Near Infrared Phototherapy in Type 2 Diabetic Neuropathy
Sponsor:
Healthlight, LLC
Organization:
Study Overview
Official Title:
Randomized Double-Blind Study of the Efficacy of Near Infrared Phototherapy on Sensation and Pain in Type 2 Diabetic Neuropathy
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study blind compromised.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ResearchNIR
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: