NCT02696070

Nociceptive Pain Fiber Response

A Multi-Center, Randomized, Sham-Controlled, Double-Blind Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Small Fiber Nerve Growth and Function in Subjects With Painful Peripheral Diabetic Neuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Regenesis Biomedical, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the effectiveness of the Provant Therapy System in improving localized nerve growth and skin perfusion in subjects with painful peripheral diabetic neuropathy of the foot.

Detailed description

The study is multi-site, randomized, double-blind, sham-controlled study of the safety and efficacy of multi-dose Provant therapy to evaluate neuronal and vascular response in the treatment of subjects with painful peripheral diabetic neuropathy. Subjects will be randomized in a 2:1 ratio to receive therapy with an active device or an identical inactive sham device. Subjects will treat at home twice daily for 60 days after which they will return to the clinic for final evaluations. Subjects will be evaluated at the research center for a Baseline/Enrollment visit and again at Day 61 where assessments for safety, concomitant medications, Sympathetic Skin Response (SSR), Nerve Conduction Velocity (NCV), Skin Perfusion Pressures (SPP), and Skin Biopsy will be completed. Subjects will be contacted via telephone at Day 14, Day 28 and Day 42 to assess adherence, safety, and concomitant medications. Subjects will also complete a Response to Study Device form which will capture their daily pain score.

Conditions

• Painful Peripheral Diabetic Neuropathy

Interventions

Type	Name	Description
DEVICE	Provant Therapy System

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-03-02
• Last updated: 2018-01-12
• Results posted: 2018-01-12

Locations

1 site across 1 country: United States