Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers: a Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 290
- 主要终点
- DFU Closure Rate
研究概览
简要总结
A Prospective, Double-blind, Multi-center, Randomized, Parallel-group safety and efficacy study of adipose-derived regenerative cells (ADRCs) in the treatment of patients with diabetic foot ulcers (DFU).
详细描述
Subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of DFU care and will need debridement as a part of their care.
Subjects will be randomly assigned to one of two groups (ADRC Group will receive standard care plus ADRC, and Control Group will receive standard care plus matched placebo).
ADRCs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. Fat harvest will occur through small volume (approximately 100-200 mL) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure.
The lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for application to an autograft site. Cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 mL) into the DFU (injected around the circumference and applied to the base of the ulcer).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo is visually indistinguishable from Active Treatment. Every patient receives Standard Care, plus either Active Treatment or Placebo.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D or T2D
- •Diabetic Foot Ulcer, from 1 to 12 months in duration
- •Wagner Grade 1 or Superficial 2
- •Adequate perfusion
- •Able to undergo liposuction
排除标准
- •Diabetic Foot Ulcer penetrates to capsule, tendon, or bone
- •Active infection
- •Non-diabetic neuropathy
- •Significant cardiovascular event within 6 months before screening
研究组 & 干预措施
Standard Care plus ARDCs
- All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
- All patients will receive standard care for their Diabetic Foot Ulcer.
- Additionally, patients randomized to the ADRC arm will receive ADRCs
干预措施: ADRCs (Device)
Standard Care plus ARDCs
- All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
- All patients will receive standard care for their Diabetic Foot Ulcer.
- Additionally, patients randomized to the ADRC arm will receive ADRCs
干预措施: standard care (Other)
Standard Care plus Placebo
- All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
- All patients will receive standard care for their Diabetic Foot Ulcer.
- Additionally, patients randomized to the Control arm will receive Placebo
干预措施: standard care (Other)
Standard Care plus Placebo
- All patients will undergo small volume liposuction, and adipose tissue harvested will be processed to ADRCs during same procedure.
- All patients will receive standard care for their Diabetic Foot Ulcer.
- Additionally, patients randomized to the Control arm will receive Placebo
干预措施: Placebo (Other)
结局指标
主要结局
DFU Closure Rate
时间窗: 12 Weeks
The rate of closure at 12 Weeks
次要结局
- Percent Reduction of Wound Area(12 Weeks)