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A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

NCT04277598 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-01-31

No results posted yet for this study

Summary

The MARSYAS II study which will be conducted in patients with diabetic foot ulcer (DFU) consists of a Lead-In Phase for safety assessment of multiple doses of the biologic investigational medicinal product (IMP) APO-2 and of a Main Phase (Phase II Study) to assess the efficacy and safety of the IMP. The phase II study will be a randomized study at multiple clinical centers and it will be double-blind meaning that neither the investigator nor the treated patient know if the IMP or a placebo is applied; the study will investigate the safety and clinical efficacy of multiple dose administrations at three dose levels of APO-2 (low dose, medium dose or high dose) compared with placebo.

Conditions

  • Diabetic Foot Ulcer (DFU)

Interventions

BIOLOGICAL

APO-2

APO-2: dose adjusted gel for topical administration.

OTHER

Placebo

Placebo gel for topical administration.

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Aposcience AG

    lead INDUSTRY

Principal Investigators

  • Hendrik J Ankersmit, Univ.Prof.Dr. · Aposcience AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2023-12-06
Completion
2023-12-06

Countries

  • Austria
  • Czechia
  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277598 on ClinicalTrials.gov