A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
Applied Biologics, LLC
Study ID
NCT07126886
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pressure Area
  • Pressure Ulcer
  • Pressure Wound
  • Ulcer, Pressure

Eligibility Criteria

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

Interventions

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

Study Details

A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.

Key Dates

Start date
Jun 11, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Debridement, off-loading, reduction of bacterial burden, and proper moisture balance using dressings.
  • Experimental: XPURT + SOC
    Single-layer amniotic membrane plus standard of care.

Primary Outcome Measure

Complete Closure [ Time Frame: 1-22 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Serena Group- MonroevilleMonroevillePennsylvania15146
Laura Serena
[email protected]
412-212-0123

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By research site
Serena Group- Monroeville· Monroeville, PA

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