Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
Study NCT ID:
NCT04332003
Status:
WITHDRAWN
Last Update Posted:
2021-02-15
First Post:
2020-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care
Sponsor:
SerenaGroup, Inc.
Organization:
Study Overview
Official Title:
A Randomized Controlled Double-Blind Multi-Center Clinical Trial Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care in the Healing of Diabetic Foot Ulcers
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care.
Detailed Description:
The general objective of this double-blind study is to test the effectiveness of RIC in a population of patients with diabetic foot ulcers: Active treatment 3x per week (RIC) plus SOC compared to Sham Comparator 3x per week and SOC
Determine median time to initial wound closure in both active and sham group.
Determine median time to initial wound closure in both active and sham group.
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?:
True
Is an FDA AA801 Violation?: