NeuropathyNCT03195868
Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
A study testing Realief Therapy in people with Neuropathy and Neuropathy, Diabetic, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
- What is being tested?
- Realief Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- pregnancy
- active cancer treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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
Read the 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.
- Conditions
- Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
- Being tested
- Realief Therapy
- Keywords
- chemotherapy, chemo-induced, CIPN
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realief TherapyDevice
Also called biopsies (skin, diagnostic not therapeutic)
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | All patients will be treated similarly in this study Receives: Device: Realief Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in epidermal nerve density and/or distribution
nerve measures include epidermal penetration points
Measured: Change at Baseline 6 weeks, 26 weeks
total nerve fiber density,
nerve measures
Measured: Change at Baseline 6 weeks, 26 weeks
Secondary outcomes (2)
Brief Pain index
Measured: 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
Measured: Change at Baseline 6 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start30 Sep 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, prospective cohort
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195868
- Sponsor's protocol ID
- 2017NTLS037
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2017
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27887804
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03195868
- Acronym / sponsor ID
- 2017NTLS037
- Conditions
- Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
- Keywords
- chemotherapy, chemo-induced, CIPN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Realief TherapyAll patients will be treated similarly in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- pregnancy
- active cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realief TherapyAlso: biopsies (skin, diagnostic not therapeutic)Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers | Device | Photobiomodulation |
Primary outcome
change in epidermal nerve density and/or distribution
Time frame: Change at Baseline 6 weeks, 26 weeks
nerve measures include epidermal penetration points
total nerve fiber density,
Time frame: Change at Baseline 6 weeks, 26 weeks
nerve measures
2 secondary outcomes
Brief Pain index
Time frame: Change at Baseline 6 weeks, 26 weeks
NTSS- Nueropathy Total Symptom Score
Time frame: Change at Baseline 6 weeks, 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Background: PubMed 27887804Argenta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Realief Therapy in people with Neuropathy and Neuropathy, Diabetic, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in epidermal nerve density and/or distribution (time frame: Change at Baseline 6 weeks, 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.