NCT00958711终止不适用
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 90
- 试验地点
- 22
- 主要终点
- Percentage of Participants With Wounds Healed at 12 Weeks
研究概览
简要总结
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.
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 —（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).
- •Diagnosis of diabetes mellitus (type I or II) adequately controlled.
- •The ulcer is greater than 4 weeks duration.
- •Three or fewer ulcers separated by > 3.0 cm distance.
- •Post-debridement, the ulcer size must be between 1 and 10 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 provide a voluntary written informed consent.
- •Able and willing to wear an off-loading orthopedic shoe.
- •Able and willing to attend scheduled follow-up visits and study related exams.
排除标准
- •Greater than 30% reduction in wound size 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.
- •Active Charcot's disease as determined by clinical and radiographic examination.
- •Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
- •Known severe anemia.
- •Known serum albumin < 2.
- •Renal failure with Creatinine > 2.
- •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
- •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
Percentage of Participants With Wounds Healed at 12 Weeks
时间窗: Week 12
Bacterial Burden
时间窗: Day 0, Week 1 - Week 12
Percentage of Participants Not Healed by Number of Days After Procedure
时间窗: Day 20, Day 40, Day 60, Day 80
Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.
Wound Healing Pathway Markers
时间窗: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
次要结局
- Number of Device Removals(Week 1 to Week 24)
- Ease of Dressing Use(Week 1 to Week 12)
- Number of Participants With Ulcer Recurrence(Week 1 to Week 24)
- Number of Device Failures(Week 1 to Week 24)
- Number of Device-related Adverse Events (AE)(Week 1 to Week 24)
- Number of Procedure-related Adverse Events (AE)(Week 1 to Week 24)
- Percentage Mean of Original Wound Size From Baseline by Week(Day 0, Week 4, Week 8, Week 12)
研究者
研究点 (22)
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