Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
4
Difficult-to-heal venous leg ulcers
Key facts
- Sponsor
- Xintela AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 28 Oct 2024 → 11 Feb 2026
- Decision date (initial)
- 2024-10-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518757-42-00
- EudraCT number
- 2022-000492-39
- ClinicalTrials.gov
- NCT05549609
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Difficult-to-heal venous leg ulcers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10024946 | Lower extremities ulcers of | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Xintela AB
- Sponsor organisation
- Xintela AB
- Address
- Medicon Village
- City
- Lund
- Postcode
- 223 81
- Country
- Sweden
Scientific contact point
- Organisation
- Xintela AB
- Contact name
- Camilla Wennersten
Public contact point
- Organisation
- Xintela AB
- Contact name
- Camilla Wennersten
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 6 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Region Skane Skanes Universitetssjukhus
Clinical Trial Unit, Entregatan 7, 222 42, Lund
CTC Clinical Trial Consultants AB
CTC Clinical Trial Consultants AB, CTC Karolinska, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala
Region Oestergoetland
Hand and Plastic Surgery, Universitetssjukhuset I, 58185, Linkoping
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Gothia Forum, Clinical Trial Center, Gröna Stråket 12, 41346 Gothenburg, Bla Straket 5, Goteborgs Annedal, Goteborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-10-28 | 2026-02-11 | 2024-10-28 | 2025-10-01 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Sweden | Acceptable 2024-10-28
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-05 | Sweden | Acceptable 2025-04-07
|
2025-04-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-11 | Sweden | Acceptable 2025-04-07
|
2025-04-11 |