NCT01353495已完成不适用
A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Stryker Trauma and Extremities2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
研究概览
简要总结
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
详细描述
The primary objective of this study is time -to - healing with wound size determination at 12 weeks.
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
- •Inclusion Criteria and Population:
- •Male or female age 18 or older
- •Informed consent must be obtained
- •Patient's ulcer must be diabetic in origin and larger than 1cm
- •Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- •Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- •Patient's ulcer must exhibit no clinical signs of infection.
- •Patient is of legal consenting age.
- •Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- •Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- •Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
- •ABIs with results of ≥0.7 and ≤1.2, OR
- •Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg
排除标准
- •Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- •Patients whose index diabetic foot ulcers are greater than 25cm
- •Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,
- •Patients whose serum creatinine levels are 3.0mg/dl or greater.
- •Patients with a known history of poor compliance with medical treatments.
- •Patients who have been previously randomized into this study, or are presently participating in another clinical trial
- •Patients who are currently receiving radiation therapy or chemotherapy.
- •Patients with known or suspected local skin malignancy to the index diabetic ulcer.
- •Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center.
- •Patients diagnosed with autoimmune connective tissues diseases.
- •Nonrevascularable surgical sites
- •Active infection at site
- •Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin
- •Any pathology that would limit the blood supply and compromise healing;
- •Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
研究组 & 干预措施
APM Graft (BIOTAPE XMTM
Experimental
graft applied to wound q 3 weeks for 12 weeks
干预措施: APM Graft (BIOTAPE XMTM) (Device)
APM Graft (BIOTAPE XMTM
Experimental
graft applied to wound q 3 weeks for 12 weeks
干预措施: Wound Debridement (Other)
standard wound care
Active Comparator
Wound debridement and gels and foams applied to wound weekly for 12 weeks.
干预措施: Wound Debridement (Other)
结局指标
主要结局
Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
时间窗: 12 Weeks
Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound
次要结局
未报告次要终点
研究者
研究点 (2)
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