Do you suffer from poorly healing foot wounds?

Do you have diabetes?

Are you interested in participating in a clinical study?

 

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 1 cm2 und 8 cm2
  • Age18 – 80 years (70 years in Czech Republic)
  • 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. You will receive a reimbursement of 30 euros per appointment for travel cost incurred.

 

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

 

 

Krankenhaus der Elisabethinen Klagenfurt

Austria

 

KLAGENFURT

Allgemeines öffentliches Krankenhaus der Elisabethinen Klagenfurt
Abteilung für Chirurgie
Völkermarkter Straße 15-19
9020 Klagenfurt am Wörthersee
T +43 (0)463 5830 – 306

 

WIEN

Wiener Gesundheitsverbund Klinik Hietzing
3. Medizinische Abteilung mit Stoffwechselerkrankungen und Nephrologie, Pavillion 5A
Wolkersbergenstraße 1
1130 Wien
T: +43 (0)1 80110 – 2342

 

LINZ

Kepler Universitätsklinikum GmbH
Klinik für Dermatologie und Venerologie
Krankenhausstr. 9, 4021 Linz
T +43 (0)5 768083 – 4101

 

 

Czech Republic

 

BRNO

Fakultní nemocnice u sv. Anny v Brně
diabetologické a edukační centrum, II. interní klinika
Pekařská 664/53
656 91 Brno

T: +420 543 181 111

 

 

 

If the efficacy of the new drug can be proven in the course of the study, an important step for a progress in the treatment of difficult to cure diabetic foot ulcers has been made! Participating in this study can help bringing a drug onto the market that will not only help yourself, but also many other people affected!