ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations

This study has been terminated.
(slow recruitment - unable to meet enrollment goals)
Sponsor:
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01528293
First received: January 27, 2012
Last updated: April 30, 2015
Last verified: April 2015
Results First Received: April 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Venous Hypertension With Ulcer
Interventions: Device: ActiVAC System
Other: Compression 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
No text entered.

Reporting Groups
  Description
ActiVAC System+ Compression Therapy

ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.

ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.

Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.

Compression Therapy Only

Standard of Care compression therapy only

ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.

Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.


Participant Flow:   Overall Study
    ActiVAC System+ Compression Therapy     Compression Therapy Only  
STARTED     1     1  
COMPLETED     0     1  
NOT COMPLETED     1     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
ActiVAC System+ Compression Therapy

ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.

ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.

Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.

Compression Therapy Only

Standard of Care compression therapy only

ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.

Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.

Total Total of all reporting groups

Baseline Measures
    ActiVAC System+ Compression Therapy     Compression Therapy Only     Total  
Number of Participants  
[units: participants]
  0     1     1  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         0     0  
>=65 years         1     1  
Gender  
[units: participants]
     
Female         0     0  
Male         1     1  
Region of Enrollment  
[units: participants]
     
United States         1     1  



  Outcome Measures
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1.  Primary:   Compare Wound Healing   [ Time Frame: 6 weeks ]

2.  Secondary:   Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take   [ Time Frame: 9 weeks ]

3.  Secondary:   Quality of Life   [ Time Frame: 9 weeks ]

4.  Secondary:   Degree of Take   [ Time Frame: 6 Weeks ]


  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
Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study. The study was terminated due to insufficient enrollment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Paul J. Kim, DPM, Director of Research, MGUH Center for Wound Healing and HBOT
Organization: Georgetown University Medical Center
phone: 202-444-3059
e-mail: Paul.J.Kim@gunet.georgetown.edu


No publications provided


Responsible Party: Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier: NCT01528293     History of Changes
Other Study ID Numbers: ActiVac
Study First Received: January 27, 2012
Results First Received: April 14, 2015
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration