Actively Recruiting
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Led by Xintela AB · Updated on 2025-05-04
6
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
Sponsors
X
Xintela AB
Lead Sponsor
V
Vinnova
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
Major
- 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 for a minimum of 6 weeks
- A surface area of the target wound of ≥2 and ≤40 cm2
Major
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Clinical Trial Center (CTC)
Gothenburg, Sweden, SE-413 46
Actively Recruiting
2
Burn Centre, Linköping University Hospital
Linköping, Sweden, SE-581 85
Withdrawn
3
Clinical Research Unit
Lund, Sweden, SE-221 85
Withdrawn
4
Clinical Trial Consultants (CTC) Karolinska
Stockholm, Sweden, SE-171 64
Actively Recruiting
Research Team
C
Central contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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