Status:
TERMINATED
ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations
Lead Sponsor:
Georgetown University
Conditions:
Chronic Venous Hypertension With Ulcer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Detailed Description
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 enr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01528293
Start Date
July 1 2012
End Date
March 1 2014
Last Update
March 19 2020
Active Locations (1)
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1
Georgetown University Hospital, Center for Wound Healing
Washington D.C., District of Columbia, United States, 20007