Neuropathy
Conditions
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.
Interventions
OTHERInfrared 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).
OTHERSham
Sponsors
Clin-Assist, LLC
Midwest Medical Research
Healthlight, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
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 14. Amputation of digit or digits are not considered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Pain (MPI Pain Scale) | 90 Days | Decrease in pain as measured by the Multidimensional Pain Inventory (MPI) pain scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Sensation | 90 Days | Improvement in sensation as measured by Michigan Neuropathy Screening (MPS) scoring |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment (incidence of treatment related AEs at each follow up visit) | 90 Days | Incidence of treatment related adverse events at each follow up visit |
Countries
United States
Outcome results
None listed