Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT05274295
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2022-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Sponsor:
Szeged University
Organization:
Study Overview
Official Title:
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.
Detailed Description:
This motive trial can help to establish rutine application of this internationaly widely used device at University of Szeged. The primary outcome is the reduction rate of the wound size. The treatment response will be calculated from wound size before and after treatment. Any AEs related to the study devide will be monitored.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: