A Prospective, Randomized, Comparative Effectiveness Trial of the ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Compare Wound Healing
研究概览
简要总结
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.
详细描述
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. The study will be conducted in the following manner:
Prescreening, Screening, and Enrollment
- Obtain informed consent
- Assess patients for eligibility based on inclusion/exclusion criteria
- Initial quality of life questionnaire completed
- Target ulcer
• If more than 1 wound is present on either leg; the target ulcer will be the one that is the largest in overall dimensions. All other ulcers will be treated per Standard of Care.
-
Photo/wound measurements
-
Venous studies (if necessary to confirm diagnosis)
-
Case Record Form (CRF) completed
-
Subjects will continue with Standard of Care until treatment initiation visit
-
If a patient is currently undergoing pump or pneumatic compression therapy, they must discontinue this treatment at least 2 week before the treatment initiation visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active infection (redness, swelling, pain, purulence)
- •Untreated osteomyelitis or current osteomyelitis
- •Allergy or sensitivity to wound study products
- •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
- •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
结局指标
主要结局
Compare Wound Healing
时间窗: 6 weeks
Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.
次要结局
- Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take(9 weeks)
- Degree of Take(6 Weeks)
- SF-12 Quality of Life Survey(9 weeks)
研究者
Christopher Attinger, M.D.
Director, Wound Healing Clinic
Georgetown University