A Prospective Randomized Controlled Blinded Study to Evaluate the Safety and Efficacy of rhPDGF-BB Saturated Collagen Wound Dressings on Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).
详细描述
Patients with diabetes are at risk for developing serious health problems that may affect the feet, eyes, kidneys, skin and heart. Foot ulcerations are of great significance to the lives of millions of diabetic patients, representing one of the most common and serious complications in these patients. Up to 25% of diabetics will develop a diabetic foot ulcer (DFU) at some point in their lifetime. The prevalence of DFUs among diabetics is 4% to 10%. More than half of all foot ulcers will become infected requiring hospitalization and 1 in 5 will require amputation. Foot ulcers account for 85,000 non-trauma related lower limb amputations annually in the USA. Every 20 seconds, somewhere in the world, a limb is lost as a consequence of diabetes. Moreover, 85% of leg amputations are preceded by DFUs and more than 60% of non-traumatic lower extremity amputations (LEA) performed in the United States each year occurs secondary to complications of diabetes mellitus. After a major amputation, 50% of patients will have another limb amputated within two years. Mortality rates subsequent to amputation are alarmingly high - up to 40% at 1 year and 80% at 5 years. Patients with a history of a DFU have a 40% greater mortality rate compared to patients with diabetes alone. Improved treatments for DFUs are clearly a matter of great significance.
In this study, the investigation will be focused on the safety and efficacy of ABSOLVE in treating diabetic foot ulcers.
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
- Double (Participant, Investigator)
盲法说明
One component of the study drug will be blinded as the study employs a placebo-controlled arm. More specifically, vials containing rhPDGF or saline will be the same Type I, sodium borosilicate vials with rubber stopper, and plastic cap. Each vial will contain 3 ml of clear liquid. The vials will have blinded labels. Type I collagen wound dressings, on the other hand, will all be the same and are not part of the blinding.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 30 to 75 years of age
- •A diagnosis of Type 1 or 2 diabetes with HbAlc between 6 and 12%, an adequate blood supply defined as TcpO2 > 30 mmHg or an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
- •A DFU 2 cm2-14 cm2 that extends into the subcutaneous tissues or beyond (≤Wagner Grade 2)
- •A DFU of at least 6 weeks duration and under care of the study investigator for at least 2 weeks following standard wound debridement with less than 30% healing
- •Body Mass Index (BMI) of 18.5 to 40 kg/m2
- •Co-morbidities are under control and non-life threatening as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests
- •A negative pregnancy test at Screening
- •Both males and WCBP agree to use acceptable contraceptive methods while on study
- •Able to comprehend and sign an ICF.
排除标准
- •Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with interpretation of safety data
- •Current or recent history of significant bacterial, fungal, viral, or mycobacterial infection
- •History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- •History of myocardial infarction, congestive heart failure, or stroke
- •History of psychotic disorder
- •History of alcoholism or drug addiction
- •Positive drug screen at Screening
- •Current treatment or treatment within 30 days prior to first dose of study products with another investigational drug or current enrollment in another clinical trial
- •Known history of HIV, hepatitis B, or hepatitis C
- •Known hypersensitivity to any of the product's components
- •Subjects who are unable or unlikely to comply with the protocol
- •Pregnant or lactating.
研究组 & 干预措施
ABSOLVE
Type I collagen sheet soaked in a solution containing rhPDGF-BB.
干预措施: RhPDGF-BB (Drug)
Placebo
Collagen sheet soaked with saline solution.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Week 0 - 24
Determine safety and tolerability of ABSOLVE on patients having a poorly healing diabetic foot ulcer.
Successful wound healing for at least two consecutive measurements. (Efficacy)
时间窗: Week 12
Successfully healed wound must remain closed for at least two consecutive measurements, one of which will be at the 12-week examination.
次要结局
- Wound Size(Week 0 - 24)
- Wound Closure(Week 0 - 24)
- Complication rate(Week 0 - 24)