Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
|ClinicalTrials.gov Identifier: NCT01549860|
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : July 30, 2015
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venous Insufficiency Venous Reflux Lower Extremity Ulcer||Device: MIST Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||April 2015|
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
- Wound Area Mean Percent Reduction [ Time Frame: 4 weeks post baseline visit (randomization visit) ]
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 ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|