NCT02309684Unknown不适用
The Clinical & Economic Evaluation of Bio-ConneKt® Wound Dressing in Treating Chronic Foot Ulcers (Diabetic and/or Venous Ulcers).
MLM Biologics Inc.,0 个研究点目标入组 20 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Time to complete wound closure
研究概览
简要总结
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound
- •The ulcer has been diagnosed/present for greater than 4 weeks duration.
- •Three or fewer ulcers separated by > 3.0 cm distance
- •Post-debridement, the ulcer size must be > 5 sq cm
- •Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:
- •transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
- •toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
- •At least 18 years old
- •Able and willing to read and sign a voluntary written informed consent
- •Able and willing to attend scheduled follow-up visits and study related exams
排除标准
- •Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator
- •Ulcer with exposed tendon or bone
- •Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- •Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
- •Known severe anemia
- •Known serum albumin < 2.5
- •Renal failure requiring dialysis
- •Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
- •Severe liver disease as defined by the treating physician or patient's primary care physician
- •Malignancy at or near the ulcer site
- •Any condition judged by the investigator that would cause the study to be detrimental to the patient
- •Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator
- •Received another investigational device or drug within 30 days of Day
- •Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment
- •Received another allograft, autograft or xenograft within 30 days of the Day 0/
- •Known allergy to equine derived tissue
- •Alcohol or drug abuse, defined as current medical treatment for substance abuse
- •Pregnant or nursing women
结局指标
主要结局
Time to complete wound closure
时间窗: Weekly assessment up to 12 weeks
Time to complete wound closure and percent wounds healed at 12 weeks
次要结局
- Rate of Wound Closure(4, 6, 12 & 24 weeks)
研究者
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