A Phase I/II, Multicentre, Randomised, 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 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 7
- 主要终点
- Incidence of complete wound closure
研究概览
简要总结
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
详细描述
After the screening visit, the eligible patient population randomly receive one of the three following topical drugs:
- BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,
- BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or
- BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or
- Beclapermin gel 6.25 µg/cm²/application for 20 weeks.
The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
- •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.
研究组 & 干预措施
Biochaperone PDGF-BB low dose
BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
干预措施: Biochaperone PDGF-BB Low dose (Drug)
Biochaperone PDGF-BB High dose
BioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
干预措施: Biochaperone PDGF-BB High dose (Drug)
Regranex
Becaplermin gel (Regranex® Gel 0.01%, Systagenix, formerly and Johnson & Johnson) is a topical gel of rhPDGF-BB conditioned in a gel tube.
干预措施: Regranex (Drug)
Very Low Dose BioChaperone PDGF-BB
BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
干预措施: Biochaperone PDGF-BB Very Low Dose (Drug)
结局指标
主要结局
Incidence of complete wound closure
时间窗: 20 WEEKS
Incidence of complete wound closure
次要结局
- Percentage reduction in total ulcer surface area at each visit.(Study duration 20 weeks)
- Time to achieve complete wound closure(Study duration 20 weeks)
- Incidence of complete wound healing at week 10(10 weeks)
- Safety Safety Measures(Study duration 20 weeks)