An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 8
- 主要终点
- Number of participants with adverse events through study completion
研究概览
简要总结
Some people with diabetes get foot ulcers that do not heal. These ulcers can get infected and cause other medical problems.
Five patients with these foot ulcers volunteered to participate in the first part of this study (C9T12015, NCT02657876). They are called Cohort 1 in this registration. Cohort 1 received one application (piece) of an experimental skin tissue to make sure it was safe.
This study will extend the safety test of the experimental skin tissue. It will find out if it is safe to use more than once to cover non-healing ulcers.
This extension will include two more groups, Cohort 2 and Cohort 3. Cohort 2 may get up to 5 applications. Cohort 3 may get up to 10 applications. The number of applications will depend on how well the wound is healing.
Participants will be in the study up to one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers will be consented. Then there will be a run-in period for the doctor to run some tests. If the tests show the study would be good for the patient, the doctor will enroll them as participants in the trial.
- •Inclusion Criteria:
- •To be considered for inclusion, a participant:
- •Agrees to practice birth control for the duration of the study
- •Has documented Type 1 or Type 2 diabetes and an HbA1C score of 10 or below
- •Has protocol-defined sufficient blood pressure and flow to the foot
- •Has stable medications for 2 weeks before treatment (other than diabetes medications or antibiotics)
- •Is able and willing to attend scheduled visits and comply with study procedures
- •If a smoker, agrees to try quitting and will accept counseling for it (Cohorts 2 and 3 only)
- •Has documented informed consent for study enrollment
- •Has had an uninfected, appropriately-sized diabetic ulcer on the foot for at least 4 weeks but not more than 1 year
排除标准
- •The doctor may not consider for inclusion a participant who:
- •Is pregnant, nursing, or a prisoner
- •Has had osteomyelitis in the foot with the ulcer in the last 30 days
- •Has a history of poor compliance
- •Has received drugs or therapies not allowed per protocol
- •Has used an investigational product within the last 60 days
- •Has ever received therapy for the study ulcer with any cell and/or tissue product (CTP)
- •Has a study ulcer in a condition not appropriate for the study
- •Has a medical condition or history that, per protocol or in the opinion of the study doctor, might put the safety of the participant in danger
结局指标
主要结局
Number of participants with adverse events through study completion
时间窗: at approximately 12 months
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
Number of participants with adverse events at Week 12
时间窗: at Week 12
Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events
次要结局
未报告次要终点