A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- complete ulcer closure
研究概览
简要总结
Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.
详细描述
A prospective investigator initiated trial will be conducted in diabetic patients with lower extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2 diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the associated morbidity. These wounds are classified utilizing the University of Texas (UT) Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection present), C (ischemia present) and D (Infection and ischemia present). This morbidity will comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the presence of treated osteomyelitis. This patient population oftentimes include diabetics with lower extremity ischemia or end stage renal disease and their associated comorbidities. These wounds are challenging in their care being they trend towards a poor prognosis including high morbidity and mortality as well as high major limb amputation rates. Hence, this trial will provide associated data to the efficacy of the above referenced material towards evaluating its effectiveness in these wound types towards enhancing wound healing and subsequently reducing amputation rates.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female age 18 or older
- •Type 1 or Type 2 diabetes mellitus
- •Signed informed consent
- •Wound present for minimum for four (4) weeks
- •Wound location foot to include the dorsal or plantar surface
- •Serum creatinine < 3.0 mg/dL
- •HbA1c< 12% taken prior to randomization
- •Patient presents with adequate circulation to the effected extremity, as demonstrated
- •by one of the following within sixty (60) days:
- •Ankle-Brachial Index (ABI) with results of >0.6 and <1.2
- •Doppler arterial waveforms which are triphasic or biphasic at ankle of affected lower extremity
- •Wound is diabetic in origin with and area of > 1 cm2 and < 16 cm2 at time of screening
排除标准
- •Unwilling to follow the visit requirements and instructions outlined by the protocol
- •Currently receiving radiation therapy or chemotherapy
- •Non-vascular surgical site
- •The subject's wound can be addressed by primary closure
- •Received growth factors, living skin, dermal substitutes, silver-containing products, amniotic membrane or umbilical cord products or other advanced biological therapies for wounds within 30 days of screening
- •Pregnant or breast feeding
- •HbA1c: > 12% within previous ninety (90) days
- •Serum creatinine level > 3.0 mg/dL Taking medications that are considered immune system modulators
- •Uncontrolled autoimmune surgical sites
- •Known or suspected local skin malignancy
研究组 & 干预措施
Treatment Group
Group that will be receiving the investigational product
干预措施: NEOX® CORD 1K® (Biological)
结局指标
主要结局
complete ulcer closure
时间窗: 16 weeks
Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.
次要结局
- recurrent ulcer-related complications(16 weeks)
- Mean cost to closure(16 weeks)
- ulcer surface area(16 weeks)
- number of days to complete wound closure(16 weeks)
- NEOX CORD 1K applications(16 weeks)