EUCTR2014-001001-40-LV进行中（未招募）1 期
A multicentre, double-blind, randomised, controlled phase II/III study to evaluate the efficacy and safety of the new wound healing solution Diperoxochloric acid (DPOCl, DermaPro®) in patients with venous leg ulcer (ulcus cruris) - DPOCl versus isotonic sodium chloride solution in patients with ulcus cruris
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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.The patient must give written informed consent, after having been informed about the benefits and potential risks of the study, as well as details of the insurance taken out to cover the patients participating in the study
- •2.Age: >18 years, inclusive
- •3.One or more chronic venous foot ulcer (ulcus cruris) between knee and ankle (lower leg) with a mean area of at least 4.0 and a maximum of 60 cm² after debridement (if indicated).. Wound shapes other than circular must have a both length and width of at least 2.0 cm,
- •4.Clinical findings consistent with established venous disease (such as skin hyperpigmentation, hypopigmentation, varicose veins, lipodermatosclerosis) confirmed by venous Doppler duplex ultrasonography.
- •5.If other ulcerations are present at the same leg, they must be >2cm apart from the target wound
- •6.Adequate perfusion of the lower leg as determined by an ABI > 0.85 for the leg to be treated
- •7.Females of non-childbearing potential defined as being amenorrheal for longer than 2 years with an appropriate clinical profile or surgically sterile.
- •If of childbearing potential the patient must use an adequate birth control and must have a negative pregnancy test.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.New ulcers (first appearance less than 4 weeks) or ulcers, which have been treated over the last 4 weeks and showed a reduction of wound size of > 25%
- •2.Target wound showed healing tendency between screening and enrolment
- •3.Local antibiotic therapy of the target wounds selected for the study
- •4.Known or suspicion of osteomyelitis at the target leg
- •5.Other wounds of different aetiology with impaired healing, such as decubitus ulcer, arterial and/or diabetic foot ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study.
- •6.Vascular reconstruction or angioplasty less than 3 months ago
- •7.Clinically significant abnormal values in clinical chemistry
- •oAdvanced renal failure (Creatinine >2mg%)
- •oSevere hepatic disease (3 times above upper normal limit)
- •oUncontrolled Diabetes mellitus (HbA1c >9%).
- •oSignificant anaemia (Hb < 10g/dl),
- •oAlbumin <2,5g/dl
- •8.Severe or uncontrolled heart failure (NYHA class III or IV)
- •9.BMI > 45.0 kg/m²
- •10.Patient is not ambulatory
- •11.Concurrent illness or a condition that may interfere with wound healing other than those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy)
- •12.Previous radiation of the region of the target wounds selected for the study
- •13.Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 6 months days prior to the study
- •14.Severe psychiatric or neurological disorder
- •15.Incapability of giving informed legal consent
- •16.Unsuitable circumference of ancle and/or wade (as defined in section 17.3) preventing adequate compression treatment
- •17.Co-worker, student, relative or spouse of the investigator
- •18.Previous participation in the study
- •19.Participation in another experimental clinical study during the previous 30 days prior to the present study
- •20.Current drug or alcohol abuse
研究者
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