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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03195868
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : October 8, 2019
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Neuropathy Neuropathy, Diabetic Neuropathy Toxic Device: Realief Therapy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, prospective cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Photobiomodulation
All patients will be treated similarly in this study
Device: Realief Therapy
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
Other Name: biopsies (skin, diagnostic not therapeutic)

Primary Outcome Measures :
  1. change in epidermal nerve density and/or distribution [ Time Frame: Change at Baseline 6 weeks, 26 weeks ]
    nerve measures include epidermal penetration points

  2. total nerve fiber density, [ Time Frame: Change at Baseline 6 weeks, 26 weeks ]
    nerve measures

Secondary Outcome Measures :
  1. Brief Pain index [ Time Frame: Change at Baseline 6 weeks, 26 weeks ]
  2. NTSS- Nueropathy Total Symptom Score [ Time Frame: Change at Baseline 6 weeks, 26 weeks ]
    This is a 15 question survey with yes or no answers. Averaged for scoring

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03195868

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Contact: Peter Argenta 612-626-6283

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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter Argenta, MD         
Sponsors and Collaborators
University of Minnesota

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Responsible Party: University of Minnesota Identifier: NCT03195868    
Other Study ID Numbers: 2017NTLS037
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota:
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases