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Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD

NCT04313985 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-06-01

Study results available
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Summary

The purpose of this study is to apply Avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.

Conditions

  • PAD - Peripheral Arterial Disease
  • PVD- Peripheral Vascular Disease

Interventions

DEVICE

Tennant Biomodulator-Pro™ Device

Tennant Biomodulator-Pro™ conductive electrode pads will be placed on both sides of the wound. The device will either deliver electrical stimulation or no stimulation depending on treatment period.

Sponsors & Collaborators

Principal Investigators

  • Geoffrey C Gurtner, MD · Stanford University School of Medicine- Plastic & Reconstructive Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04313985 on ClinicalTrials.gov