Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07089602
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Sponsor:
BioLab Holdings
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Status:
RECRUITING
Status Verified Date:
2025-07
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:
BIOCAMP
Brief Summary:
The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Detailed Description:
This study is a multi-center, prospective, randomized controlled clinical study consisting of 650 subjects from up to 30 centers. The subjects are randomized to receive 1 of 4 treatments, either with Tri-Membrane Wrap™ (HPM-1); Membrane Wrap™ (HPM-2); Membrane Wrap-Lite™ (HPM-3); Membrane Wrap-Hydro™ (HPM-4); and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of HPM-1 - HPM - 4 + SOC or SOC alone until or up to 12 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the HPM arm or (2) change the standard of care dressing in the control arm. A trial design diagram is found in Figure 3.
Study Oversight
Has Oversight DMC:
False
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?: