EUCTR2016-004782-11-SE进行中（未招募）1 期
A Phase 1/2A Prospective, Dose-Escalation, Open-Label Study of the Safety, Feasibility, and Initial Efficacy of Subcutaneous Plasminogen (Human) 10 for the Treatment of Diabetic Foot Ulcer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female aged 18-90 years (both inclusive)
- •2) Subject has signed informed consent
- •3) Diagnosed with type 1 or type 2 diabetes
- •4) Presence of a single ulcer on a foot that meets the following criteria:
- •Ulcer is below the malleolus and attributed to diabetes
- •Ulcer is in location that would allow multiple adjacent SC injections
- •Ulcer is of full skin thickness and may involve tendon or capsule, but does not probe to bone
- •Ulcer surface area is between 1-10 cm2 (both inclusive); NOTE: subject may have one or more DFUs on the other foot; if a subject has a single ulcer on both feet, and both ulcers are in locations that could receive SC injections, then the ulcer with the larger surface area should be chosen for study, provided it is 1-10 cm2 in size
- •5) Has received standard treatment of DFU for 4 weeks in investigator’s clinic before screening
- •6) Toe pressure >40 mm Hg
- •7) Female subjects of childbearing potential who are sexually active with a non-sterile male partner must have a negative urine pregnancy test at baseline and agree to use adequate birth control from screening throughout the study and for 4 weeks after the last IMP administration.
- •If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 4 weeks after the last IMP administration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1) History of hypersensitivity reaction to blood products, plasma-derived products, or aprotinin
- •2) Treatment with exogenous plasminogen (such as fresh frozen plasma), or a fibrinolytic agent (such as recombinant tissue plasminogen activator or streptokinase) during the 2 weeks before screening
- •3) Presence of osteomyelitis, gangrene, or cellulitis requiring intravenous (IV) antibiotic treatment.
- •NOTE: Subjects using oral antibiotics for well-controlled cellulitis are eligible, provided the following criteria are also met:
- •- Subject must have started the oral antibiotics prior to enrolment and be finishing a course of treatment
- •- Well-controlled” means no clinical sign of active infection” at the time of screening and baseline exams
- •- Active infection” is defined as the presence of 2 or more of the following: frank purulence, local warmth, erythema, lymphangitis, oedema, pain, fever, and foul smell
- •- Subjects receiving treatment for an infection with MRSA or other multi-resistant organism will be excluded regardless of the appearance of the wound
- •4) History of malignancy treated in past 3 years (except for basal cell skin cancer)
- •5) Creatinine >2x the upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3x ULN
- •6) HbA1c >90 mmol/mol
- •7) Treatment with cytostatic drugs, growth factors, immunosuppressive drugs, or anti-fibrinolytics (such as aminocaproic acid, tranexamic acid, or aprotinin) within 2 weeks before screening visit
- •8) Other significant medical condition that the investigator or sponsor determines could interfere with compliance or study assessments (such as: dementia, substance abuse, and end-stage renal/hepatic/cardiac disease)
- •9) If female: pregnant or lactating
- •10) Has participated in another investigational drug or medical device study for any medical condition during the 4 weeks prior to screening
研究者
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