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Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

NCT07725419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Diabetic Peripheral Neuropathic Pain (DPN)
  • Diabetic Peripheral Neuropathy
  • Diabetic Peripheral Neuropathic Pain

Interventions

DEVICE

NMS 460 Pulsed Radio Frequency Device

Active transcutaneous electrical pulsed radio frequency stimulation. The device is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks.

DEVICE

Placebo Device

A sham device designed to look and operate like the active device but delivering no therapeutic current. It is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks to mimic the active treatment.

Sponsors & Collaborators

  • Xavant Technology (Pty) Ltd

    collaborator UNKNOWN

  • Algiamed Technologies USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Phyllis P Berger · Faculty: University of the Witwatersrand

  • Stanley S Landau · Centre for Diabetes and Endocrinology (CDE)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • South Africa

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 NCT07725419 on ClinicalTrials.gov