A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Wound Closure by Week 15
研究概览
简要总结
The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.
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
- Single (Outcomes Assessor)
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
- •(Answering NO will exclude patient):
- •An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
- •The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week
- •Subjects between 18 and 85 years of age.
- •Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.
- •The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.
- •Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
- •Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
- •Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
- •Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
- •For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
- •Subject understands the requirements of this study and is willing to comply with all the study requirements.
排除标准
- •(Answering YES will exclude patient):
- •The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
- •The subject is diagnosed with HIV/AIDS.
- •The subject is diagnosed with any bleeding disorders.
- •The subject is diagnosed with any connective tissue diseases.
- •For female subjects, the subject is pregnant or lactating.
- •The subject has a history of illicit drug use within one year of enrollment.
- •In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
- •The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
- •Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
- •The subject is diagnosed with active Charcot as described by Saunder's classification system.
- •The subject manifests signs of poor nutritional status and/or albumin level < 2.
- •The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.
- •The study ulcer size is less than 0.5 cm2 or greater than 25 cm
- •The subject has any porcine allergy or cow product allergy.
- •The subject's recent (last 30 days) chemistry tests serum creatinine is 2 times above the upper limit of normal and/or LFT's 3 times above the upper limit of normal.
- •Between Visit 1/Week -2 and Visit 3/Week 0 (randomization) the study ulcer has decreased in size by more than 40%, or increased in size by more than 50%.
研究组 & 干预措施
Dermagraft
debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape
干预措施: debridement, irrigation (Procedure)
Dermagraft
debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape
干预措施: Dermagraft (Device)
Oasis
debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape
干预措施: SECONDARY dressing gauze and tape (Device)
Standard of care
debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape
干预措施: SECONDARY dressing gauze and tape (Device)
Standard of care
debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape
干预措施: debridement, irrigation (Procedure)
Dermagraft
debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape
干预措施: SECONDARY dressing gauze and tape (Device)
Oasis
debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape
干预措施: debridement, irrigation (Procedure)
Oasis
debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape
干预措施: Oasis (Device)
结局指标
主要结局
Wound Closure by Week 15
时间窗: 15 weeks
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
次要结局
- Cost Effectiveness(12 weeks)
- Wound Closure at 20 Weeks(20 weeks)