Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Percent of subjects with study wound deemed closed at 12 weeks
研究概览
简要总结
This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.
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
- •Subjects who have Diabetic Foot Ulcer located at the pad of the foot or the heel of the foot with a surface area range < 1 sq. cm to 25 sq. cm and < 5 cm in widest diameter on lower extremity, but larger than 1 sq. cm. Diabetics included will be those with HBA1C ≥ 6.5 % and ≤ 12%
- •Subjects with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to .7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to .6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30 mmHg)) or and alternative biphasic and triphasic waveforms, doppler waveform, or DP+PT
- •Subjects are ambulatory
- •Subjects aged 18 - 85
- •All genders
- •All ethnic backgrounds
排除标准
- •Subjects without decisional capacity
- •Subjects unable to give informed, written consent
- •Subjects with active infection (redness, swelling, pain, suppuration)
- •Subjects with osteomyelitis
- •Subjects with a malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum
- •Subjects with active Charcot Arthropathy of the foot
- •Subjects with uncontrolled hyperglycemia (HbA1C > 12 %)
- •Subjects with end stage renal disease, creatinine > 3.0mg/dl within 6 months
- •Subjects with previous Rx with NPWT, growth factors, hyperbaric O2, or bioengineered tissue product within 30 days of enrollment
- •Subject has a > 30% wound Surface area reduction in size at 2 wk after screening
- •Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
- •Subjects under steroid therapy, unless taking dose of 5mg/dl or less
- •Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
研究组 & 干预措施
Syntrfuge Microfragmented Fat
Debridement, Microfragmented Adipose Tissue Injectable, Camboot
干预措施: Syntrfuge Microfragmented Fat (Device)
Standard of Care
Debridement and Camboot
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Percent of subjects with study wound deemed closed at 12 weeks
时间窗: 12 weeks
Full Wound Healing
时间窗: 12 weeks
The main study outcome will be time taken to achieve full wound closure, as determined by standard 12-week wound healing milestones defined by PERI and other clinical trials in this space
次要结局
- Safety of Intervention(4 months)
- Safety of Intervention measured by number of Adverse and Significantly Adverse Events(4 months)