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MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

NCT01671748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2015-08-26

Study results available
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Summary

Chronic venous leg ulcers (VLUs) impact negatively on patients' quality of life. Standard treatment in the UK for patients with VLUs is compression bandaging or stockings. The MIST ultrasound system is a noncontact device which delivers low frequency ultrasound through a gentle saline mist directed at a patient's wound. This study aims to determine whether the use of the MIST device used in combination with standard treatments can improve healing of VLUs compared to UK standard practice. This will be assessed by measuring any reduction in wound size in the two groups after receiving 8 weeks of either Standard Care once a week or MIST combined with Standard Care three times a week.

Conditions

  • Varicose Ulcer

Interventions

DEVICE

MIST ultrasound therapy

Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.

OTHER

Standard Care

Compression bandaging, non-adherent dressing, and debridement if required.

Sponsors & Collaborators

  • Celleration, Inc.

    collaborator INDUSTRY

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Keith G Harding, Professor · Wound Healing Research Unit, Cardiff University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United Kingdom

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 NCT01671748 on ClinicalTrials.gov