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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: Completed NA study, sponsored by Regenesis Biomedical.
NCT03455543 is a NA study that has completed, run by Regenesis Biomedical. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).
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 |
What the finished NCT03455543 record still lists
NCT03455543 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Provant Therapy System is the first listed.
NCT03455543 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03455543's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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