A phase I/II/, multicentre, randomized, controlled and open label trial comparing the efficacy and safety of three dose regimens of BioChaperone PDGF-BB to becaplermin gel for the treatment of diabetic foot ulcer.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 9
- 主要终点
- The incidence of complete wound healing
研究概览
简要总结
Diabetic foot ulcer is a common complication of diabetes that occurs in an estimated 15% of diabetic patients. Infection and gangrene, the two major complications of ulcers, lead to amputation in 4 to 7 per 1.000 patients with diabetes. With an over 5% worldwide prevalence of diabetes, the morbidity and mortality and the expenses associated with diabetic foot ulcers are substantial both for the patients and for the health care systems. The standard wound care of diabetic foot ulcer relies primarily on pressure relief, debridement and maintenance of a moist wound environment. In addition, growth factor therapy with platelet-derived growth factor (PDGF-BB) has demonstrated significant clinical benefit by increasing the incidence of complete wound closure and by accelerating wound healing. RhPDGF-BB formulated as a gel (Regranex® Gel 0.01%, Systagenix Wound Management, formerly Johnson & Johnson; and Healace®, Virchow Biotech Pvt, Ltd) is the only growth factor approved for the treatment of neuropathic diabetic foot ulcers. However, the limited efficacy of Regranex® Gel (healing rate only increased by 15% versus placebo, still leaving 50% of the patients unhealed), the inconvenience of the treatment regimen (daily application of the gel and once or twice daily wound care), and the high cost of the associated nursing care are strong impediments to its use in routine ulcer care management. Adocia has developed BioChaperone PDFG-BB, a new liquid formulation designed for an application of rhPDGF-BB as a spray, and only every two days, hence reducing the burden and nursing cost associated with the gel dose regimen. The aim of this study is to establish the proof of concept in a Phase I/II clinical trial with two objectives: i) establish equivalence to Regranex® Gel with two major advantages (improved compliance and reduced nursing care and thus costs), and ii) assess the efficacy of a double dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
- •2.Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
- •?Chronic ulcer of at least six weeks despite appropriate wound care.
- •Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
- •Well controlled infection or cellulitis (systemic antibiotherapy).
- •Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
- •Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
- •Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening.
- •Non-nursing.
- •Signed informed consent before any study procedure.
排除标准
- •Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
- •Active ulcer infection assessed by clinical examination and radiographic if necessary.
- •Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.?Active osteomyelitis affecting the area of the target ulcer.
- •?Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
- •Known connective tissue or malignant disease.
- •Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
- •Use of investigational drug/device within 30 days.
- •Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
- •Vascular reconstruction within 8 weeks.
- •Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
结局指标
主要结局
The incidence of complete wound healing
时间窗: 20weeks
次要结局
- Time to achieve complete wound closure(10 weeks)
- percentage reduction in total ulcer surface area at each visit(once in a week)