EUCTR2012-002100-41-SE进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, safety and pilot dose-response study of LL-37 in hard-to-heal venous leg ulcers
ipopeptide AB0 个研究点目标入组 35 人开始时间: 2012年5月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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 subjects >18 years of age and post-menopausal or clinically sterile women.
- •2.Subjects with VLU, or combined venous-arterial ulcers with predominant venous component.
- •3.Subjects whose leg ulcers have failed to heal within 6 weeks of compression therapy.
- •4.Ankle-Brachial Pressure Index (ABI) >0.70 at screening.
- •5.Ulcer localization above the foot and below the knee (wrist and malleoli included).
- •6.Surface area of target ulcer 1-40 cm2 at screening.
- •7.Ulcer essentially free of necrotic tissue.
- •8.Ability to tolerate compression bandaging.
- •9.Subjects should be in an appropriate state of health to participate in the study, as determined by the Investigator. This will be determined by a medical history, physical examination, and clinical laboratory evaluations.
- •10.Subjects willing to attend study site visits and able to communicate effectively.
- •11.Subjects who have voluntarily signed and dated a patient IRB/EC approved Informed Consent Form (ICF).
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1.Other known predominant etiology than VLU of the target ulcer.
- •2.Malignant disease (excluding basal cell carcinoma) unless in remission for 5 years.
- •3.Subjects who have a past or present disease that, which as judged by the Investigator, may affect the safety of the subject or the outcome of the study.
- •4.Hematology values deviating 25% or more from the upper or lower limits of the normal range, and judged by the Investigator to affect the safety of the subject or the study outcome.
- •5.Liver function tests (ALT, AST, ALK PHOS and bilirubin) deviating 50% or more from the upper normal limits, and judged by the Investigator to affect the safety of the subject or the study outcome..
- •6.P-albumin <25 g/L or HbA1C >10%.
- •7.Presence of active psoriasis skin lesions within 1.5 cm of the ulcer area.
- •8.Ulcer that by location or extension will either be difficult to assess or to treat according to the protocol.
- •9.Presence of a non-study ulcer within 1 cm of the target VLU.
- •10.Exposure of bone, tendon or fascia within the target wound.
- •11.Clinical signs or symptoms of a clinical wound infection, erysipelas, or osteomyelitis.
- •12.Systemic immunosuppressive drugs with the exception of low-dose oral steroids: glucocorticoids corresponding to oral Prednisolone =10 mg/day, which is allowed provided that drug treatment was initiated within 4 weeks prior to screening visit, and at that time point, expected to be maintained at similar dose level throughout the study period. Also, mineral corticoids may be permitted.
- •13.Known hypersensitivity to any component of the trial product or standard wound dressing allowed during study treatment period or follow-up period.
- •14.Systemic treatment with antibiotics for target ulcer infection within 7 days prior to screening visit.
- •15.Participation in another clinical trial within 7 days prior to screening visit
- •16.Treatment with any of the following medications: topical antibiotics, and potassium permanganate.
- •17.Reduction in wound area per week* during run-in period:
- •a. >7% for a an ulcer with an initial area of >10 cm2
- •b.>10% for an ulcer with an initial area of 2-10 cm2
- •c.>13% for an ulcer with an initial area of <2 cm2
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