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Study blind compromised.
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| Name | Class |
|---|---|
| Clin-Assist, LLC | UNKNOWN |
| Midwest Medical Research | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Pain (MPI Pain Scale) | Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Sensation | Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment (incidence of treatment related AEs at each follow up visit) | Incidence of treatment related adverse events at each follow up visit | 90 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kipp Van Camp, DO | Midwest Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Medical Research | Topeka | Kansas | 66604 | United States |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Other |
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