Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420245
Status:
WITHDRAWN
Last Update Posted:
2024-06-25
First Post:
2024-05-14
Brief Title:
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
Sponsor:
Legacy Medical Consultants
Organization:
Legacy Medical Consultants
Study Overview
Official Title:
A Prospective Post-market Randomized Controlled Trial RCT to Demonstrate the Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer DFU Wound Management
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBOUND
Brief Summary:
The goal of this clinical trial is to learn if use of Orion TM a dual-layer amniotic membrane allograft in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers The main question it aims to answer is the incidence of complete wound closure at the end of 12 weeks of treatment Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves patient outcomes
Participants will visit their doctor weekly over a 12 week period as per standard diabetic foot ulcer treatment procedures and fill out a questionnaire measuring quality of life
Participants will visit their doctor weekly over a 12 week period as per standard diabetic foot ulcer treatment procedures and fill out a questionnaire measuring quality of life
Detailed Description:
Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States The purpose of this study is to evaluate the clinical utility of Orion TM a dual-layer amniotic membrane allograft versus standard wound care in the management of diabetic foot ulcers Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone For only partially healed wounds investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone
Study Oversight
Has Oversight DMC:
None
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?:
None