A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers (NCT05549609) | Clinical Trial Compass
CompletedPhase 1/2
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
Sweden6 participantsStarted 2022-10-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 for a minimum of 6 weeks
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability: Adverse events (AEs)
Timeframe: From study start to 4 months after dosing
2
Safety and tolerability: Local tolerability
Timeframe: From study start to 4 months after dosing
3
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
Timeframe: From study start to 4 months after dosing
4
Safety and tolerability: Number of participants with abnormal vital signs
Timeframe: From study start to 4 months after dosing
5
Safety and tolerability: Number of participants with abnormal laboratory test results
Timeframe: From study start to 4 months after dosing
6
Safety and tolerability: Number of participants with abnormal physical examination findings
Timeframe: From study start to 4 months after dosing