A randomized, placebo-controlled, double-blind study to evaluate safety and dose dependent clinical efficacy of APO-2 at three different doses in patients with diabetic foot ulcer (MARSYAS II) - MARSYAS II

Aposcience AG0 个研究点目标入组 120 人2020年5月13日

适应症Diabetic Foot Ulcer MedDRA version: 24.0Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Diabetic Foot Ulcer
发起方: Aposcience AG
入组人数: 120
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年5月13日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Aposcience AG

入排标准

入选标准

•1\. Patient is between 18 and 80 years of age
•2\. Patients with Type I or Type II diabetes with a glycosylated hemoglobin (HbA1c) of \= 12%, obtained at enrollment or within 30 days prior to study enrollment
•3\. Patients who have a wound defined as diabetic foot ulcer present for \= 4 weeks
•4\. Foot ulcer Wagner grade I– II or ARMSTRONG grade I\-A (superficial, non\-infected, non\-ischemic wound not involving tendon, capsules, or bone) or II\-A (non\-infected, non\-ischemic wound penetrating to tendon or capsule but not to the bone or joint) – Annex 2
•5\. Estimated foot ulcer surface area between \= 0\.8 cm2 and \= 8 cm2 as measured at day of randomization assessed using the eKare imaging and measurement device
•6\. A patient with more than one diabetic foot ulcer may be included in the study but only one ulcer will be selected for the investigational treatment based on Investigator judgment as far as the ulcer meets the inclusion criteria (the largest ulcer fitting the inclusion criteria will be selected as index ulcer)
•7\. Wound area has not changed by more than 30 % between screening visit and randomization visit (at least 14 days)
•8\. Adequate arterial blood perfusion measured on the leg with treated wound (ABI \[ankle brachial index] \=0\.5 \[the lowest ABI measured value will be used as reference], or toe pressure \> 40 mmHg, or tcPO2 \> 40 mmHg) within the past 6 months including patients with mild to moderate peripheral arterial disease (Fontaine Stage I and II)
•9\. Patient must adhere to off\-loading of the ulcer area (in mobile patients adherence to off\-loading footwear during the study is mandatory)
•10\. Patient is able to give written informed consent prior to study start and to comply with the study requirements

排除标准

•1\. History of anaphylaxis, known hypersensitivity to sodium alginate, propylene glycol, methylene\-blue or chicken\-egg
•2\. Target ulcer is over a deformity (such as Charcot deformity) that interferes with off\-loading based on investigator's opinion
•3\. Index wound duration of \> 3 years without intermittent healing
•4\. Clinical evidence of ulcer bed infection or patients requiring intravenous (IV) antibiotics to treat the index wound infection at time of randomization
•5\. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site, or documented history of osteomyelitis at the target wound location during the 8 weeks preceding the screening visit
•6\. Major uncontrolled medical disorder(s) such as severe uncontrolled leg edema, concurrent medication, or other issue that renders the patient unsuitable for participation in the study, including but not limited to: comorbid condition with an estimated life expectancy of \= 12 months, hemoglobin A1c (Hba1c) \> 12% at screening, patients on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA IV, uncontrolled hypertension systolic BP by repeated measurement \> 180mmHg)
•7\. Raynaud disease or any other severe peripheral microvascular disease, current diagnosis of vasculitis
•7a. Patients with PAD who
•\- have not been assessed by vascular imaging as per standard of care or
•\- have acute peripheral artery occlusion of the index extremity or