Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
5
Countries
1
Sites
1
chronic wounds
Key facts
- Sponsor
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- 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 Mar 2021 → 24 Sep 2025
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518789-29-00
- EudraCT number
- 2019-004637-16
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
chronic wounds
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Sponsor organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Address
- Calle De Isaac Peral 42 Oficinas 2a Planta Oficina 1
- City
- Madrid
- Postcode
- 28015
- Country
- Spain
Scientific contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Contact name
- Lucia Llanos
Public contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
- Contact name
- Lucia Llanos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 5 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2021-03-15 | 2025-09-24 | 2021-03-22 | 2025-06-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Spain | Acceptable 2024-10-18
|
2024-10-18 |