A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percent of wounds healed
研究概览
简要总结
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
详细描述
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medicare eligible
- •A full thickness diabetic foot ulcer with a viable wound bed
- •Diabetes mellitus (type I or II) that is adequately controlled
- •The ulcer is greater than 4 weeks duration.
- •The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel).
- •Post-debridement, the ulcer size must be between 0.5 - 20 cm
- •One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle; or toe pressure of >40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
- •Able and willing to provide a voluntary written informed consent.
- •Able and willing to wear an off-loading device or orthopedic shoe
- •Able and willing to attend scheduled follow-up visits and study related exams
排除标准
- •Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator
- •Wagner 3, 4, 5 DFU
- •Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- •Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates).
- •Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA))
- •Presence of Gangrene
- •Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
- •Malignancy at or near the ulcer site
- •Known serum albumin < 2.5 mg/dl, Known renal failure as determined by a Creatinine > 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL
- •Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
- •Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis &/or the following abnormal Liver Function Tests: ALT & AST >35, ALP >120, PT >12 seconds.
- •Presence of additional abnormal lab values obtained within 7 days prior to the Day 0 visit determined to be clinically significant by the investigator including: WBC >13,000/cm3 or < 5, 000 cm3, or electrolytes that are outside the host institution's range of normal.
- •Radiation therapy, chemotherapy, chronic steroid use or immunosuppressive therapy within 30 days of enrollment
- •Received another investigational device or drug within 30 days of enrollment
- •Received allograft, autograft or xenograft within 30 days of enrollment
- •Subject has inadequate venous access for repeated blood draw required for Eclipse RPR administrations
- •Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
- •Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
- •Any condition judged by the investigator that would cause the study to be detrimental to the subject
- •Alcohol or drug abuse, defined as current medical treatment for substance abuse
- •Pregnant or nursing women
结局指标
主要结局
Percent of wounds healed
时间窗: 12 weeks
Percentage of closure of the wound
Time to complete wound closure
时间窗: 12 weeks
Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks
次要结局
- Wound Trajectory(4, 8, 12 weeks)
- Ulcer Recurrence(3 months)
- Quality of Life score(3 months)