Cellular and Matrix-like Products for Bed Sores
AK
KH
Overseen ByKhristina Harrel
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Tiger Biosciences, LLC.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
Research Team
TS
Thomas Serena, MD
Principal Investigator
Serena Group
Eligibility Criteria
This trial is for individuals with nonhealing pressure ulcers, commonly known as bed sores. Participants should meet specific criteria to join the study, but those details are not provided here.Inclusion Criteria
I agree to attend all weekly study visits.
My ulcer is between 2 cm2 and 100 cm2 in size after cleaning.
The potential subject must be willing and able to participate in the informed consent process
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Exclusion Criteria
The potential subject's target ulcer is not a pressure ulcer
The potential subject is known to have a life expectancy of < 3 months
The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either CAMPs plus SOC or matched SOC controls for the management of nonhealing pressure ulcers
20 weeks
Weekly visits for assessment and treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- ACApatch™
- caregraFT™
Trial Overview The study is testing the effectiveness of different products called CAMPs (caregraFT™ and ACApatch™) combined with standard wound care against just the usual wound care alone in treating nonhealing pressure ulcers.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: caregraFT™ + SOCExperimental Treatment1 Intervention
Human amniotic membrane tissue allografts derived from human placental tissue.
Group II: ACApatch™ + SOCExperimental Treatment1 Intervention
Human amniotic membrane tissue allografts derived from human placental tissue.
Group III: Standard of CareActive Control1 Intervention
Standard of care will be cleaning, debridement, and ulcer moisture balance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tiger Biosciences, LLC.
Lead Sponsor
Trials
8
Recruited
8,000+
ExtremityCare, LLC.
Collaborator
SerenaGroup, Inc.
Collaborator
Trials
32
Recruited
3,900+
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