NCT01108263终止4 期
The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Decrease in Wound Size
研究概览
简要总结
- After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group.
- Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit.
- Both groups will be debrided and have pictures taken in the OR
- Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR.
- Subjects will be placed in a total contact cast at each visit.
If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
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
- •Subject is 18 years of age or older
- •Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.
- •Subject has Diabetes Mellitus (type 1 or type 2).
- •University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².
- •Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
排除标准
- •Subjects < 18 years of age
- •Subject is non-diabetic
- •Subjects who present with wounds of etiology other than diabetes
- •Subject demonstrates increased signs of clinical infection
- •Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- •University of Texas Classification greater than grade 1A
- •Diabetic plantar foot wounds measuring >4.0cm²
- •Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing
- •Subjects participating in any other trials in regards to the diabetic foot ulcer
研究组 & 干预措施
Integra Flowable on wound bed
Active Comparator
INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
干预措施: INTEGRA™ Flowable Matrix (Collagen) (Drug)
INTEGRA Flowable on wound & injected subcutaneously
Active Comparator
INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
干预措施: INTEGRA™ Flowable Matrix (Collagen) (Drug)
结局指标
主要结局
Overall Decrease in Wound Size
时间窗: 12 weeks
次要结局
- Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.(12 weeks)
研究者
John Steinberg, DPM
Principle Investigator
Georgetown University
研究点 (1)
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