Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Diabetic foot ulcus
Key facts
- Sponsor
- Cell2cure ApS
- 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
- 15 Dec 2022 → 28 Nov 2025
- Decision date (initial)
- 2023-07-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505961-10-00
- EudraCT number
- 2022-001589-37
- ClinicalTrials.gov
- NCT05595681
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Diabetic foot ulcus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10012664 | Diabetic foot ulcer | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cell2cure ApS
- Sponsor organisation
- Cell2cure ApS
- Address
- Kajeroedgaard 9
- City
- Birkeroed
- Postcode
- 3460
- Country
- Denmark
Scientific contact point
- Organisation
- Cell2cure ApS
- Contact name
- CEO & Clinical Director
Public contact point
- Organisation
- Cell2cure ApS
- Contact name
- CEO & Clinical Director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Bispebjerg Hospital
Copenhagen Diabetes Foot Center, Department of Endocrinology, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen Nv
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 |
|---|---|---|---|---|---|
| Denmark | 2022-12-15 | 2022-12-15 | 2025-11-28 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-30 | Denmark | Acceptable 2023-06-14
|
2023-07-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-24 | Denmark | Acceptable 2023-09-18
|
2023-09-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-15 | Denmark | Acceptable 2024-01-23
|
2024-02-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-03-08 | Denmark | Acceptable 2024-04-02
|
2024-04-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-18 | Denmark | Acceptable 2024-04-02
|
2024-07-18 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-22 | Denmark | Acceptable 2024-04-02
|
2024-07-22 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-22 | Denmark | Acceptable 2024-07-23
|
2024-07-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-21 | Denmark | Acceptable with conditions 2025-06-06
|
2025-06-06 |