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NCT Number: NCT03195868

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

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

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Key information

Conditions

Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Neuropathy Toxic Neuropathy, Diabetic Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Realief Therapy

Device

Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers

Other names: biopsies (skin, diagnostic not therapeutic)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2017
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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