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

NCT01528293 | Terminated Results

• 1 other identifier: ActiVac
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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 receive Vacuum Assisted Closure (V.A.C. or VAC) by means of the ActiV.A.C. + 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.

Conditions

Chronic Venous Hypertension With Ulcer

Outcome Measures

Primary Outcomes (1)

• Compare Wound Healing

  Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

  6 weeks

Secondary Outcomes (3)

• Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take

  9 weeks

• SF-12 Quality of Life Survey

  9 weeks

• Degree of Take

  6 Weeks

Study Arms (2)

ActiVAC System+ Compression therapy

ACTIVE COMPARATOR

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

Device: ActiVAC System; Other: Compression therapy

Compression therapy only

OTHER

Standard of Care compression therapy only

Other: Compression therapy

Interventions

ActiVAC System DEVICE

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.

Also known as: ActiV.A.C System

ActiVAC System+ Compression therapy

Compression therapy OTHER

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.

ActiVAC System+ Compression therapy; Compression therapy only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active infection (redness, swelling, pain, purulence)
• Untreated osteomyelitis or current osteomyelitis
• Allergy or sensitivity to wound study products
• Malignancy
• Plantar surface wounds
• BMI (Body Mass Index) ≥50
• Uncontrolled diabetes (HbA1c\>12%) at the time of study screening
• End stage renal disease
• Undergoing chemotherapy/radiation therapy
• Non-dopplerable pedal pulses or otherwise diagnosed with peripheral arterial disease or any contraindication to compression therapy
• 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
• Greater than 35% wound surface area reduction in size at 2 weeks after initial screening visit
• Pregnancy
• Subject has any condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
• Subject unwilling or unable to comply with protocol requirements

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Hospital, Center for Wound Healing

Washington D.C., District of Columbia, 20007, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Paul J. Kim, DPM, Director of Research, MGUH Center for Wound Healing and HBOT
• Organization: Georgetown University Medical Center

Paul.J.Kim@gunet.georgetown.edu

202-444-3059

Study Officials

• Christopher Attinger, M.D

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Wound Healing Clinic

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 8, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 19, 2020
• Results First Posted: May 18, 2015

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)