Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
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
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2021
CompletedJune 9, 2022
June 1, 2022
1.3 years
June 1, 2017
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Brief Pain index
Change at Baseline 6 weeks, 26 weeks
NTSS- Nueropathy Total Symptom Score
Change at Baseline 6 weeks, 26 weeks
Study Arms (1)
Photobiomodulation
EXPERIMENTALAll patients will be treated similarly in this study
Interventions
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
Eligibility Criteria
You may qualify if:
- willingness to undergo biopsies and 6 weeks of therapy
You may not qualify if:
- pregnancy
- active cancer treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22.
PMID: 27887804BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2017
First Posted
June 22, 2017
Study Start
September 30, 2019
Primary Completion
January 21, 2021
Study Completion
January 21, 2021
Last Updated
June 9, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share