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 sites132 target enrollmentNovember 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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)
•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

•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