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The Effects of Pulsed Elelectro-Magnetic Fields ("PEMF") in the Treatment of Venous Stasis Leg Ulcers

NCT03416049 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2024-04-05

No results posted yet for this study

Summary

The purpose of this study is to determine the clinical effectiveness of a low-power PEMF device, a medium-power PEMF device and a high-power PEMF device as compared to a sham device to treat leg ulcers resulting from venous stasis ("VSLU").

Conditions

  • Venous Stasis Ulcers

Interventions

DEVICE

PEMF therapy with a high-power PEMF device

The 20 participants assigned to a high-power PEMF device will treat each Venous Stasis Leg Ulcer (VSLU) area for 10 minutes twice a day.

DEVICE

PEMF therapy with a medium PEMF power device

The 20 participants assigned to a medium-power PEMF device will treat each VSLU area for 15 minutes twice a day.

DEVICE

PEMF therapy with a low-power PEMF device

The 20 participants assigned to a low-power PEMF device will treat each VSLU area for 30 minutes twice a day.

DEVICE

PEMF therapy with the sham PEMF device

The 20 participants assigned to the sham PEMF device will treat each VSLU area for 15 minutes twice a day.

Sponsors & Collaborators

  • Henry Ford Health System

    collaborator OTHER

  • PEMF Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Aamir Siddiqui, MD · Division Head, Plastic Surgery, Henry Ford Hospital

  • Guillemette Epailly, BS, MArch · PEMF Systems, Inc.

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2023-01-20
Completion
2023-01-20

Countries

  • United States

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 NCT03416049 on ClinicalTrials.gov