drugset / Trial / NCT05549609
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2022-10-26
- Primary completion
- 2026-02-11
- Completion
- 2026-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XSTEM-VLU | Cell therapy | — | Topical |