Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05301816 · ClinicalTrials.gov registry record · NA
PDN Post Market, Multicenter, Prospective, Global Clinical Study
A NA study of Diabetic Neuropathy, Painful, sponsored by Nevro.
- Recruiting
- Registry status
- NA
- Development phase
- 497
- Enrollment target
- 8
- Study locations
NCT05301816: Recruiting NA study of Diabetic Neuropathy, Painful, sponsored by Nevro.
NCT05301816 is a NA study of Diabetic Neuropathy, Painful that is actively recruiting participants, run by Nevro. The registered enrollment target is 497 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05301816, a NA study of Diabetic Neuropathy, Painful, is actively recruiting participants, sponsored by Nevro.
- RECRUITING
- Registry status
- NA
- Development phase
- 497 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.
Primary Outcome
Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.
Conditions Studied
Interventions
- DEVICE Spinal Cord Stimulator (SCS)
Study Locations (8)
Michigan
- Michigan Pain Specialists - Ann Arbor
- Henry Ford Health - West Bloomfield
Alaska
- Neuroversion, Inc. - Anchorage
Ohio
- Ohio State University Wexner Medical Center - Columbus
Oklahoma
- Clinical Investigations, LLC - Edmond
Oregon
- Columbia Pain Management - Milwaukie
Pennsylvania
- WellSpan Interventional Pain Specialists - York
Virginia
- Virginia Interventional Pain & Spine Centers - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2028-10 |
| Phase | NA |
What NCT05301816 shows while recruiting
NCT05301816 is an interventional study that assigns participants to a tested intervention. The registered 497 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 (65% lower).
The record links to 1 condition, with Diabetic Neuropathy, Painful appearing as the primary indexed condition, and to 1 intervention - of which Spinal Cord Stimulator (SCS) is the first listed.
NCT05301816 lists 8 locations in 7 states (Michigan, Alaska, Ohio).
Frequently Asked Questions
What is clinical trial NCT05301816 about?
NCT05301816 is a clinical study titled "PDN Post Market, Multicenter, Prospective, Global Clinical Study". The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner d...
What is the current status of trial NCT05301816?
This trial is currently recruiting. It is a NA study. The enrollment target is 497 participants. The study started on 2022-07-05. Estimated completion is 2028-10.
What conditions does trial NCT05301816 study?
This clinical trial studies the following conditions: Diabetic Neuropathy, Painful.
What interventions are being tested in trial NCT05301816?
The interventions under investigation include: Spinal Cord Stimulator (SCS) (DEVICE).
Who is sponsoring clinical trial NCT05301816?
This trial is sponsored by Nevro, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05301816 being conducted?
This trial has 8 study locations across Alaska, Michigan, Ohio, Oklahoma, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Neuropathy, Painful
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05301816's enrollment target sits among peer trials
497 213th of 2000 higher than 1,788 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03175224 · 497 participants · Phase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
- NCT05766670 · 497 participants · Phase 3
Intramedullary Calcium Sulfate Antibiotic Depot
- NCT05283720 · 496 participants · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- NCT06417775 · 496 participants · Phase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI