Clinical Trial

Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

Completed
View on ClinicalTrials.gov →
Summary
The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief. In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.
Trial Details
NCT Number NCT07725419
Lead Sponsor Algiamed Technologies USA, Inc.
Collaborators: Xavant Technology (Pty) Ltd
Conditions Diabetic Peripheral Neuropathic Pain (DPN), Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathic Pain
Enrollment 92 participants
Start Date 2016-12
Primary Completion 2019-08 (estimated)
Study Completion 2019-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-24