Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449638
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Sponsor:
StimLabs
Organization:
StimLabs
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMPSTIM
Brief Summary:
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane also defined as Cellular Acellular Matrix-like Productsskin substitutes plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design
Detailed Description:
The CAMPSTIM trial is a prospective multicenter randomized controlled clinical trial to evaluate four separate CAMPs Cellular Acellular Matrix-like Products Revita Relese Cogenex and Enverse The study utilizes a unique modified platform trial to evaluate multiple cellular andor tissue-based products CTPs in a single trial
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