MARSYAS II

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

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What is the clinical study about – what is being investigated?

This clinical trial is a scientific study of patients with diabetic foot ulcers. The study drug used in this clinical trial is called APO-2 and is in clinical development as a drug for external use and has not yet been approved.
APO-2 is being investigated for the treatment of wound healing disorders in skin wounds. The aim of the study is to prove that a new drug (gel) is well tolerated for the treatment of poorly healing, diabetic foot wounds. One possible benefit of the new drug is faster and more permanent wound closure.
Since this is a placebo-controlled study, it is possible that instead of the drug, you will also receive a gel without novel active ingredients. In any case, however, you will receive intensive treatment of your wound by experienced doctors.

What are the requirements for my participation in the clinical study?

• diabetic wound on the foot (Wagner grade I-II), which has existed for more than 4 weeks but less than 3 years, of a size between 0.8 cm² und 8 cm²
• Age18 – 80 years
• excluded are patients on dialysis, with severe cardiovascular or malignant diseases (among other)

Treatment course

Initial examination and treatment by medical staff including blood sampling and urinalysis, possibly prescribing pressure-relieving measures.
Observation of the wound: 2 to 4 weeks, then further examination including neurological tests on the tactile sensation of the foot, followed by random assignment to one of four groups: 75 % of the participants receive the study drug (in one of three different concentrations), 25 % receive a placebo preparation that does not contain any active substances. In any case, you will receive professional wound care with close-knit check-ups and dressing changes.
Treatment period: 3 treatments per week, 4 weeks (application of the gel and wound care at the center)
Follow-up treatment: 3 check-ups after 2 weeks, 4 weeks, and 3 months after the end of active treatment
It is necessary to come to the study center on the scheduled dates. The drug cannot be taken home.

If we have piqued your interest please contact the study center in your area or ask yout treating dictor.
You are also welcome to contact the listed study centers by phone.

You can also find further information at:
https://www.clinicaltrials.gov/ct2/show/NCT04277598
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04948-1