MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

This study has been completed.
Sponsor:
Collaborator:
Celleration, Inc.
Information provided by (Responsible Party):
Professor Keith G Harding, Cardiff University
ClinicalTrials.gov Identifier:
NCT01671748
First received: August 21, 2012
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: June 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Varicose Ulcer
Interventions: Device: MIST ultrasound therapy
Other: Standard Care

  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
Study procedures took place in a single dedicated unit specialising in wound healing research, between August 2012 and November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled patients received 4 weeks of SOC prior to random allocation (run-in phase). Patients whose wounds reduced by >40% in the first 4 weeks were withdrawn and did not progress to random allocation.

Reporting Groups
  Description
Standard of Care Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
NLFU and Standard of Care Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.

Participant Flow for 2 periods

Period 1:   4 Week run-in Phase
    Standard of Care     NLFU and Standard of Care  
STARTED     47     0  
COMPLETED     36     0  
NOT COMPLETED     11     0  
Withdrawal by Subject                 1                 0  
Adverse Event                 1                 0  
Not eligible                 9                 0  

Period 2:   12 Week Treatment Phase
    Standard of Care     NLFU and Standard of Care  
STARTED     19     17  
COMPLETED     19     17  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Standard of Care Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
NLFU and Standard of Care Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
Total Total of all reporting groups

Baseline Measures
    Standard of Care     NLFU and Standard of Care     Total  
Number of Participants  
[units: participants]
  19     17     36  
Age  
[units: years]
Mean (Standard Deviation)
  68.2  (12.2)     70.5  (12.7)     69  (12.0)  
Gender  
[units: participants]
     
Female     12     9     21  
Male     7     8     15  
Region of Enrollment  
[units: participants]
     
United Kingdom     19     17     36  
History of leg ulceration (months)  
[units: months]
Mean (Standard Deviation)
  94.7  (83.2)     109.7  (112.2)     101.8  (96.8)  
Index ulcer duration (months)  
[units: months]
Mean (Standard Deviation)
  22.3  (18.5)     15.7  (12.0)     19  (16)  
Wound size at enrolment (cm^2)  
[units: cm^2]
Mean (Standard Deviation)
  19.4  (14.9)     15.9  (9.9)     17.8  (12.7)  
Change in wound size during run-in phase (%)  
[units: percentage change in wound area]
Mean (Standard Deviation)
  -13.0  (25.2)     -10.9  (23.9)     -12.0  (24.3)  



  Outcome Measures
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1.  Primary:   Percentage Change in Wound Area   [ Time Frame: Week 5 to 13 ]

2.  Primary:   Actual Change in Wound Area   [ Time Frame: Week 5 to 13 ]

3.  Secondary:   Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)   [ Time Frame: Week 1 (start) and week 13 (exit) ]

4.  Secondary:   Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)   [ Time Frame: Weeks 5 to 13 ]

5.  Secondary:   Incidence of Wound Infection   [ Time Frame: Weeks 5 to 13 ]

6.  Secondary:   Number of Non-serious Adverse Events in Each Group   [ Time Frame: Week 5 to 13 ]

7.  Secondary:   Wound Recurrence Rate   [ Time Frame: 90 days after time of healing ]


  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

Difference in treatment frequency between the groups which could potentially bias results.

Standard deviation proved to be larger than estimated from the available literature which resulted in the study having reduced statistical power.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Judith White
Organization: Cardiff and Vale University Health Board
phone: 02920744771
e-mail: judith.white3@wales.nhs.uk


No publications provided


Responsible Party: Professor Keith G Harding, Cardiff University
ClinicalTrials.gov Identifier: NCT01671748     History of Changes
Other Study ID Numbers: 12-SUR-5323
Study First Received: August 21, 2012
Results First Received: June 4, 2015
Last Updated: July 29, 2015
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service