Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03455543 · ClinicalTrials.gov registry record · NA
Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy
A NA study, sponsored by Regenesis Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
NCT03455543 is a NA study that has completed, run by Regenesis Biomedical. The registered enrollment target is 182 participants.
The verdict
NCT03455543, a NA study, has completed, sponsored by Regenesis Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
Study Summary
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
Interventions
- DEVICE Active Provant Therapy System
- DEVICE Inactive (sham) Provant Therapy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2018-03-26 |
| Est. Completion | 2019-07-18 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03455543
The ClinicalTrials.gov registry entry for NCT03455543 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regenesis Biomedical, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active Provant Therapy System is the first listed.
NCT03455543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03455543 about?
NCT03455543 is a clinical study titled "Dual Field PEMF Therapy in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy". Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes tw...
What is the current status of trial NCT03455543?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2018-03-26. Estimated completion is 2019-07-18.
What interventions are being tested in trial NCT03455543?
The interventions under investigation include: Active Provant Therapy System (DEVICE), Inactive (sham) Provant Therapy System (DEVICE).
Who is sponsoring clinical trial NCT03455543?
This trial is sponsored by Regenesis Biomedical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.