Neuralgia > Axon Therapy

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

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NeuraLace Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests whether Axon Therapy combined with regular medical care can reduce nerve pain in diabetic patients. The study involves patients with painful diabetic neuropathy. Axon Therapy might work by sending signals to the nerves to help lessen pain.

Eligibility Criteria

Participant Groups

Group I: Axon Therapy + CMM Experimental Treatment 1 Intervention

Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.

Group II: Sham + CMM Placebo Group 1 Intervention

Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.

Find A Clinic Near You

Research locations nearby Select from list below to view details:

SC Pain and Spine Specialists, LLC Murrells Inlet, SC

Florida Pain Management Associates, P.A. Sebastian, FL

Truwell Health Saint Petersburg, FL

Centurion Spine and Pain Centers Waycross, GA

More Trial Locations

Who is running the clinical trial?

NeuraLace Medical, Inc. Lead Sponsor

References