A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
- Registration Number
- NCT05549609
- Lead Sponsor
- Xintela AB
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Single topical dose of CryoStor CS10 XSTEM-VLU XSTEM-VLU Single topical dose of XSTEM-VLU
- Primary Outcome Measures
Name Time Method Safety and tolerability: Adverse events (AEs) From study start to 4 months after dosing Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Safety and tolerability: Local tolerability From study start to 4 months after dosing Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG) From study start to 4 months after dosing Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal physical examination findings From study start to 4 months after dosing Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal vital signs From study start to 4 months after dosing Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
Safety and tolerability: Number of participants with abnormal laboratory test results From study start to 4 months after dosing Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.
- Secondary Outcome Measures
Name Time Method Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline From study start to 4 months after dosing Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS) From study start to 4 months after dosing The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline From study start to 4 months after dosing Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline From study start to 4 months after dosing Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS) At week 10 and at 4 months after dosing The POSAS is divided into two scales (for patient and for observer), each with six items scored numerically (1 -10). The lowest score "1" corresponds to normal skin.
Trial Locations
- Locations (4)
Clinical Trial Center (CTC)
🇸🇪Gothenburg, Sweden
Burn Centre, Linköping University Hospital
🇸🇪Linköping, Sweden
Clinical Research Unit
🇸🇪Lund, Sweden
Clinical Trial Consultants (CTC) Karolinska
🇸🇪Stockholm, Sweden