NCT02260609已完成4 期
A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- 100% granulation of wound as determined by the investigator
研究概览
简要总结
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 years and 85 years of age inclusive, as of the date of screening
- •Confirmed diagnosis of Type I or Type II Diabetes
- •Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
- •Wound is located on the foot below the malleoli
- •Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
- •Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
- •Patient has adequate circulation to the foot as documented by either:
- •Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or
- •In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 > 30 mmHg, or
- •Skin perfusion pressure > 30 mmHg
排除标准
- •Index Wound is of non-diabetic pathophysiology
- •Gangrene is present on any part of the affected foot
- •Index Wound is over a Charcot deformity
- •The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
- •Patient has a glycated hemoglobin A1 (HbA1c) level of >14%
- •Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
- •Patient has a wound within 15cm of the Index Ulcer identified for study consideration
- •Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
- •Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
- •Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
- •Patient has active malignancy other than non-melanoma skin cancer
- •Patient's random blood sugar is >450 mg/dl at screening
- •Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator
- •Pregnant women
- •Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- •Patient has allergy to primary or secondary dressing materials used in this trial
- •Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
- •In the opinion of the Investigator, the patient is unsuitable for participation in the study
结局指标
主要结局
100% granulation of wound as determined by the investigator
时间窗: Up to 16 weeks after the Initial Treatment Visit
次要结局
- Measurement of percent wound area reduction as determined by the investigator(Up to 16 weeks after the Initial Treatment Visit)
- Closure of wound defined by 100% re-epithelialization(Up to 16 weeks after the Initial Treatment Visit)
- Number of applications of Grafix®(Up to 16 weeks after the Initial Treatment Visit)
- Time to 100% granulation(Up to 16 weeks after the Initial Treatment Visit)
研究者
研究点 (8)
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