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Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

NCT01549860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2015-07-30

Study results available
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Summary

This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care (SOC) alone in the treatment of lower extremity venous ulcers.

Conditions

  • Venous Insufficiency
  • Venous Reflux
  • Lower Extremity Ulcer

Interventions

DEVICE

MIST Therapy

Non-contact low frequency ultrasound therapy

Sponsors & Collaborators

  • Celleration, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Gibbons, MD · South Shore Hospital

  • Vicki Driver, DPM · Providence RI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-05-31
Completion
2015-04-30

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 NCT01549860 on ClinicalTrials.gov