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

Stopped early · Not applicable

Conditions studied: Chronic Venous Hypertension With Ulcer

In brief

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.

Key facts

Study ID: NCT01528293
Run by: Georgetown University
People needed: 2
Starts: 2012-07-01
Expected to finish: 2014-03-01
Last updated by the study team: 2020-03-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Georgetown University Hospital, Center for Wound Healing — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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