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Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study

NCT01540981 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-01-15

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.

Conditions

  • Wound of Skin

Interventions

DEVICE

MIST Therapy

FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.

OTHER

Standard of Care

Standard of Care consists of pressure relief, wound cleansing and dressing as needed

Sponsors & Collaborators

  • Celleration, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce Black, PhD, RN · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-07-31

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 NCT01540981 on ClinicalTrials.gov