Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01549860
First received: March 7, 2012
Last updated: July 2, 2015
Last verified: July 2015
Results First Received: April 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Venous Insufficiency
Venous Reflux
Lower Extremity Ulcer
Intervention: Device: MIST Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
156 subjects were consented for the study, 112 subjects met the major inclusion/exclusion criteria (study cohort), 81 subject were randomized (reduced <30% during run-in period).

Reporting Groups
  Description
Standard Care (SC) 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
SC + 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.

MIST Therapy: Non-contact low frequency ultrasound therapy


Participant Flow:   Overall Study
    Standard Care (SC)     SC + Mist Therapy  
STARTED     40     41  
COMPLETED     38     40  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 0  
Physician Decision                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible subjects randomized

Reporting Groups
  Description
Standard Care (SC) 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
SC + 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.

MIST Therapy: Non-contact low frequency ultrasound therapy

Total Total of all reporting groups

Baseline Measures
    Standard Care (SC)     SC + Mist Therapy     Total  
Number of Participants  
[units: participants]
  40     41     81  
Age  
[units: years]
Median (Full Range)
  60.0   (34.0 to 81.0)     58.0   (33.0 to 86.0)     59.0   (33.0 to 86.0)  
Gender  
[units: participants]
     
Female     11     13     24  
Male     29     28     57  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     11     13     24  
White     24     22     46  
More than one race     5     6     11  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     40     41     81  
BMI  
[units: kg per meter squared]
Median (Full Range)
  33.2   (21.2 to 55.7)     37.4   (17.2 to 69.7)     34.7   (17.2 to 69.7)  
Wound Age at Randomization  
[units: months]
Median (Full Range)
  8.9   (1.7 to 204.5)     10.3   (1.5 to 114.0)     10.3   (1.5 to 204.5)  
Wound Area at Randomization  
[units: centimeters squared]
Median (Full Range)
  9.8   (2.5 to 36.9)     12.4   (3.1 to 53.3)     11.0   (2.5 to 53.3)  



  Outcome Measures
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1.  Primary:   Wound Area Mean Percent Reduction   [ Time Frame: 4 weeks post baseline visit (randomization visit) ]

2.  Secondary:   Heal Rates   [ Time Frame: 12 weeks post randomization ]

3.  Secondary:   Change in Pain VAS Scores   [ Time Frame: Baseline, 2 weeks and 4 weeks post randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pamela Unger
Organization: VP Medical Affairs
phone: (952) 224-8755
e-mail: punger@celleration.com


No publications provided


Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01549860     History of Changes
Other Study ID Numbers: IN-BALANCE VLU
Study First Received: March 7, 2012
Results First Received: April 27, 2015
Last Updated: July 2, 2015
Health Authority: United States: Institutional Review Board