Text Size

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

This study is currently recruiting participants.
Verified March 2013 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01528293
First received: January 27, 2012
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a prospective, randomized, comparative interventional human subject trial. Patients with a chronic venous ulceration of the lower extremity will be enrolled into this study. These wounds must be recalcitrant to the standard treatment regimen. There are a total of two arms in this study. One group will be randomly assigned to the Acti VAC + Compression therapy group consisting of the application of this device along with compression therapy. The other group will be randomly assigned into compression therapy only group. A total of 60 subjects will be enrolled into this 6 week study. There will be a 2 week run-in period (prior to the onset of the intervention) to ensure that the wound has not healed greater than 35% prior to intervention and randomization. Wounds that heal within the 6 week trial period will have an additional confirmatory visit 2 weeks after healing was identified.

If within the 6 week intervention period the wound bed is determined to be ready for a Split Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT), the surgery or clinic application will be scheduled within 4 weeks. Subjects deemed not to be a surgical candidate, will have Bio-engineered Alternative Tissue (BAT) application in the clinic. This includes patients who are medically unstable to receive a medical clearance for surgery or otherwise not a candidate for Split Thickness Skin Graft (STSG) surgery (e.g. donor site skin is compromised). During this period between the scheduled STSG surgery or BAT application, the subjects will continue within the assigned treatment group. A confirmatory visit will also occur 2 weeks after the application of a Split Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT).

Patients diagnosed with a chronic venous ulceration will be assessed for study eligibility during their initial clinical evaluation. Patients who meet the eligibility requirements will be asked to enroll into the study (see Subject Recruitment). Subjects will be asked to sign the informed consent form and receive a copy of the informed consent.


Condition Intervention
Chronic Venous Hypertension With Ulcer
 Device: ActiVAC System + Compression therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Comparative Effectiveness Trial of the ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Compare wound healing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    -Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

  • Quality of Life [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

  • Degree of take [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ActiVAC System+ Compression therapy
ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.
 Device: 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.

Other Name: ActiV.A.C System
compression therapy only
Standard of Care compression therapy only
 Device: 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.

Other Name: ActiV.A.C System

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects between 18-75 years of age
  2. Subject able and willing to comply with study protocol requirements and able to understand the informed consent
  3. Non-pregnant female willing to take urine pregnancy test

  4. Chronic venous ulceration of the lower extremity

    • Defined: wound of greater than 1 month in duration
    • Diagnosis based on clinical assessment and/or venous studies
    • <100 cm2 area and <10cm at the widest diameter

Exclusion Criteria:

  1. Active infection (redness, swelling, pain, purulence)
  2. Untreated osteomyelitis or current osteomyelitis
  3. Allergy or sensitivity to wound study products
  4. Malignancy
  5. Plantar surface wounds
  6. BMI (Body Mass Index) ≥50
  7. Uncontrolled diabetes (HbA1c>12%) at the time of study screening
  8. End stage renal disease
  9. Undergoing chemotherapy/radiation therapy
  10. Non-dopplerable pedal pulses or otherwise diagnosed with peripheral arterial disease or any contraindication to compression therapy
  11. Any previous wound care therapy including negative pressure therapy, ultrasound therapy, BAT, or STSG within the previous 30 days of enrollment; this excludes compression therapy
  12. Greater than 35% wound surface area reduction in size at 2 weeks after initial screening visit
  13. Pregnancy
  14. Subject has any condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
  15. Subject unwilling or unable to comply with protocol requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528293

Contacts
Contact: Paul Kim, DPM 202-444-0469 Paul.J.Kim@gunet.georgetown.edu
Contact: Mallory W Nichols, B.S 202-444-0283 Mallory.W.Nichols@gunet.georgetown.edu

Locations
United States, District of Columbia
Georgetown University Hospital, Center for Wound Healing Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Christopher Attinger, MD            
Sub-Investigator: John Steinberg, DPM            
Sub-Investigator: Paul Kim, DPM            
Sub-Investigator: Karen K. Evans, MD            
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Christopher Attinger, M.D Georgetown University Hospital
Study Director: Paul Kim, DPM Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Christopher Attinger, M.D., Director, Wound Healing Clinic, Georgetown University
ClinicalTrials.gov Identifier: NCT01528293     History of Changes
Other Study ID Numbers: ActiVac
Study First Received: January 27, 2012
Last Updated: March 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Ulcer
Varicose Ulcer
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013