Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruiting
Participants planned
60
Countries
1
Sites
7
Diabetic foot
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nimes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 2 Jul 2024 → ongoing
- Decision date (initial)
- 2023-09-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500541-24-00
- ClinicalTrials.gov
- NCT02664740
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Diabetic foot
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10012664 | Diabetic foot ulcer | 10040785 |
| 20.1 | PT | 10060803 | Diabetic foot infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nimes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nimes
- Address
- 4 Place Du Professeur Robert Debre
- City
- Nimes Cedex 9
- Postcode
- 30029
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- Christophe MASSEGUIN, Project Manager
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- Christophe MASSEGUIN, Project Manager
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 60 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Service de Médecine tropicale et pathologies infectieuses, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier De Tourcoing
Service Universitaire des Maladies Infectieuses et du Voyageur, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Intercommunal de Villeneuve Saint Georges
Service de Médecine Interne, Maladies Infectieuses et Tropicales, 40, allée de la source, Villeneuve-Saint-Georges
Centre Hospitalier Universitaire De Nimes
Service des Maladies Infectieuses et tropicales, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Universitaire De Nimes
Service de Maladies Métaboliques et Endocriniennes, Place Du Professeur Robert Debre, 30900, Nimes
Hopital Europeen Marseille
Service de Médecine interne, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier Universitaire De Toulouse
service de Diabétologie -Maladies Métaboliques- Nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
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 |
|---|---|---|---|---|---|
| France | 2024-07-02 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-02 | France | Acceptable 2023-09-18
|
2023-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-18 | France | Acceptable 2025-04-01
|
2025-04-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-03 | France | Acceptable 2025-09-15
|
2025-09-29 |