At a glance
ClinicalIndex Comparison RecordN/ACompleted· 156 enrolled
Drug / intervention
MIST Therapydevice
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.
IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing
In Brief
A clinical study evaluating MIST Therapy for Venous Insufficiency and 2 related conditions. Completed, enrolled 156 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Insufficiency, Venous Reflux, Lower Extremity Ulcer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionMay 2014
Study CompletionApr 2015
TodayJul 2026
First PostedMar 9, 2012
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.3 years ago
Interventions
MIST Therapydevice
Non-contact low frequency ultrasound therapy