CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
MIST ultrasound therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01671748
NCT01671748N/ACompleted

Pragmatic Randomised Controlled Trial of MIST Ultrasound Therapy Compared to UK Standard Care for the Treatment of Non-healing Venous Leg Ulcers.

Cardiff and Vale University Health Board·interventional·Posted Aug 24, 2012·Updated Aug 26, 2015

In Brief

A clinical study evaluating MIST ultrasound therapy and Standard Care for Varicose Ulcer. Completed, enrolled 47 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Ulcer
CountriesUnited Kingdom
CollaboratorsCelleration, Inc.

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 24, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago

Interventions

MIST ultrasound therapydevice

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

Standard Careother

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