Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
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.
Lower Extremity Ulcer
Device: MIST Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing|
- Wound Area Mean Percent Reduction [ Time Frame: 4 weeks post baseline visit (randomization visit) ] [ Designated as safety issue: No ]
Compare between the treatment groups percent wound area reduction at four weeks of study treatment.
H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size.
- Heal Rates [ Time Frame: 12 weeks post randomization ] [ Designated as safety issue: No ]Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.
- Change in Pain VAS Scores [ Time Frame: Baseline, 2 weeks and 4 weeks post randomization ] [ Designated as safety issue: No ]
Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization
Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates "no pain" and the right end of line indicates "worst pain imaginable". VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.
H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,
Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons.
|Study Start Date:||April 2012|
|Study Completion Date:||April 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
No Intervention: Standard of Care
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
Experimental: SOC + Mist Therapy
30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.
Device: MIST Therapy
Non-contact low frequency ultrasound therapy
The study compared the treatment effect of non-contact low frequency ultrasound in addition to standard of care versus standard of care alone in healing chronic venous leg ulcers in subjects who had documented venous stasis and reflux. Subjects that were screened and met the major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist wound healing dressings, and debridement for a two week run-in period. If their study ulcer did not decreased by greater than 30% they were eligible for randomization. The primary endpoint was wound area reduction after four (4) weeks of study treatment. The study was performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis and a wound recidivism registry that are ongoing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549860
|United States, Massachusetts|
|South Shore Hospital|
|Weymouth, Massachusetts, United States, 02189|
|Principal Investigator:||Gary Gibbons, MD||South Shore Hospital|
|Principal Investigator:||Vicki Driver, DPM||Providence RI|