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 6 months after treatment, the patients will return to the clinic for an end-of-study visit.
| Condition | Venous Leg Ulcer |
|---|---|
| Treatment | Vehicle, XSTEM-VLU |
| Clinical Study Identifier | NCT05549609 |
| Sponsor | Xintela AB |
| Last Modified on | 21 September 2023 |
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