Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-24 @ 6:58 AM
Study NCT ID:
NCT03723603
Status:
TERMINATED
Last Update Posted:
2020-03-18
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Sponsor:
Medline Industries
Organization:
Study Overview
Official Title:
A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to a re-prioritization of ongoing studies.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: