Overview
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.
The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.
Eligibility
Major Inclusion Criteria:
- Written informed consent for participation in the study
- Male or female patient aged ≥18 years
- BMI ≥18.5 and ≥40.0 kg/m2
- Lower leg wound due to venous insufficiency
- Target wound has failed to heal despite standard wound care including compression therapy for a minimum of 6 weeks
- Patient who has been compliant to their prescribed compression therapy over the (at least) 6 weeks prior to screening
- A surface area of the target wound of ≥2 and ≤40 cm2
Major Exclusion Criteria:
- Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment
- History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus
- B-HbA1C value ≥52 mmol/mol
- Plaque psoriasis or any other skin disease that could interfere with the outcome of the study
- Arterial insufficiency
- History of any malignancy within the past 5 years
- Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis
- Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants