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Electrical Stimulation to Accelerate Wound Healing

NCT03821675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-05-09

Study results available
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Summary

A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed by AVAZZIA to accelerate wound healing, relieve pain and improve mobility in patients with diabetic foot ulcers.

Conditions

Interventions

DEVICE

Electrical Stimulation - Active

Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.

DEVICE

Electrical Stimulation - Sham

Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.

Sponsors & Collaborators

  • Avazzia, Inc

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-03-15
Completion
2021-10-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03821675 on ClinicalTrials.gov