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Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

NCT05620225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-07-11

No results posted yet for this study

Summary

Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).

Conditions

  • Neuralgia
  • Neuropathic Pain
  • Painful Diabetic Neuropathy

Interventions

DEVICE

Axon Therapy and CMM

transcutaneous magnetic stimulation (TMS)

DEVICE

Sham and CMM

Sham and CMM

Sponsors & Collaborators

  • NeuraLace Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Joe Milkovits · NeuraLace Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-08-23
Completion
2023-11-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620225 on ClinicalTrials.gov