Evaluating 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

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
Tiger Biosciences, LLC.
Study ID
NCT06999590
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Pressure Injury
  • Pressure Ulcer
  • Ulcer
  • Ulcer, Pressure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ACApatch™ — OTHER
    Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
  • caregraFT™ — OTHER
    Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
  • Standard of Care — OTHER
    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance) until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Jun 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACApatch™ + SOC
    Human amniotic membrane tissue allografts derived from human placental tissue.
  • Experimental: caregraFT™ + SOC
    Human amniotic membrane tissue allografts derived from human placental tissue.
  • Active Comparator: Standard of Care
    Standard of care will be cleaning, debridement, and ulcer moisture balance.

Primary Outcome Measure

Complete closure [ Time Frame: 1-20 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Serena GroupMonroevillePennsylvania15146
Laura Serena
[email protected]
412-212-0123

Find similar trials in Monroeville, PA

By research site
Serena Group· Monroeville, PA

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