Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-13 @ 12:24 PM
Study NCT ID:
NCT01657318
Status:
TERMINATED
Last Update Posted:
2018-08-14
First Post:
2012-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers
Sponsor:
De La Salle University Medical Center
Organization:
Study Overview
Official Title:
A Prospective Observational Study on the Use of a Olivamine-containing Products in the Management of Patients With Compromised Nonhealing Lower Extremity Ulcers
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
challenges encountered in the methodology and concerns with the gold standard of treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the investigators hypothesize that the use of olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers is feasible in the Philippine setting. It will result in complete ulcer healing or wound closure after 16 weeks.
Detailed Description:
The specific aim of this study is to assess the feasibility of using olivamine-containing products in the management of patients with compromised nonhealing lower extremity ulcers in the Philippines. The primary endpoint of which is to evaluate the efficacy of Olivamine on healing of chronic lower extremity ulcers which will be assessed by rate of change in ulcer size (wound healing trajectory) and proportion with complete ulcer healing (wound closure) at 4, 8, 16 and 16 weeks compared to baseline, week 0.
Study Oversight
Has Oversight DMC:
False
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?: