Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy

Study Overview
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Brief Summary
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This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients

Detailed Description
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Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.

Official Title
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A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy

Conditions
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Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic

Intervention / Treatment
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* Device: Realief Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self reported neuropathy following exposure to diabetes or chemotherapy willingness to undergo biopsies and 6 weeks of therapy Exclusion Criteria: pregnancy active cancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, prospective cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br>All patients will be treated similarly in this study | Device: Realief Therapy<br>* Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers<br>* Other names: biopsies (skin, diagnostic not therapeutic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in epidermal nerve density and/or distribution | nerve measures include epidermal penetration points | Change at Baseline 6 weeks, 26 weeks | 
| total nerve fiber density, | nerve measures | Change at Baseline 6 weeks, 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain index |  | Change at Baseline 6 weeks, 26 weeks | 
| NTSS- Nueropathy Total Symptom Score | This is a 15 question survey with yes or no answers. Averaged for scoring | Change at Baseline 6 weeks, 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, chemo-induced, CIPN