Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584617
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective 8-week Multi-centre Randomised Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal with a Reference Amorphous Hydrogel in Subjects with Shallow Non-infected Chronic Diabetic Foot Ulcer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus type 1 or 2 and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue It will also learn about the safety of medical device Berovenal
The main questions it aims to answer are
Does medical device Berovenal lower the size of diabetic foot ulcer
What medical problems do participants have when using medical device Berovenal
Researchers will compare medical device Berovenal to a reference device device with similar purpose of use
Participants will
Use medical device Berovenal or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed
Visit the clinic once every 2 weeks for checkups and tests
Keep a diary of their symptoms and the number of times they use medical device Berovenal or a reference device
The main questions it aims to answer are
Does medical device Berovenal lower the size of diabetic foot ulcer
What medical problems do participants have when using medical device Berovenal
Researchers will compare medical device Berovenal to a reference device device with similar purpose of use
Participants will
Use medical device Berovenal or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed
Visit the clinic once every 2 weeks for checkups and tests
Keep a diary of their symptoms and the number of times they use medical device Berovenal or a reference device
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None