NCT01657474已完成不适用
A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean time to healing
研究概览
简要总结
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in 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
- •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).
- •Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two week run in period will precede enrollment/randomization in the trial to document the indolent nature of the wounds selected
- •Additional wounds may be present but not within 3cm of the study wound
- •Wound must be present anatomically on the plantar surface of the foot
- •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.
- •Serum Creatine less then 3.0mg/dl
- •HbA1c less than 12%
- •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 triphasic or 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 HbA1c 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 diagnosed with autoimmune connective tissues diseases.
- •Non-revascularizable surgical sites
- •Active infection at site
- •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
- •Patient who are pregnant or breast feeding
- •Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
- •Allergy to Gentamycin or Streptomycin
- •Wounds greater than one year in duration without intermittent healing
- •Wound improving greater than 20% over the first two weeks of the trial using standard of care dressing and Cam Boot
研究组 & 干预措施
Weekly Application of EpiFix
Experimental
Weekly application of EpiFix plus standard of care
干预措施: Weekly application of EpiFix plus standard of care (Other)
Biweekly application of EpiFix
Experimental
Biweekly application of EpiFix plus standard of care
干预措施: Biweekly application of EpiFix plus standard of care (Other)
结局指标
主要结局
Mean time to healing
时间窗: up to 12 Week
次要结局
- Percent change in wound area(Week 4 and Week 12)
- Proportion of completely healed ulcers(Week 4 and Week 12)
研究者
研究点 (2)
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