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

NCT07126886 | Recruiting Phase 4

• 1 other identifier: XPURT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer; Ulcer, Pressure; Pressure Wound; Pressure Area

Outcome Measures

Primary Outcomes (1)

• Complete Closure

  The percentage of target ulcers achieving complete wound closure in 20 weeks.

  1-22 Weeks

Secondary Outcomes (7)

• Time to Healing

  1-22 Weeks

• Percentage of Wound Area Reduction

  1-22 Weeks

• Adverse Events

  1-22 Weeks

• Measure Pain

  1-22 Weeks

• Measure Quality of Life

  1-22 Weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Debridement, off-loading, reduction of bacterial burden, and proper moisture balance using dressings.

Other: Standard of Care

XPURT + SOC

EXPERIMENTAL

Single-layer amniotic membrane plus standard of care.

Other: XPURT + SOC

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.

Standard of Care

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.

XPURT + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The potential subject must be at least 18 years of age or older.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject must have a full thickness pressure ulcer NPIAP stage 3 through stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
• At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post debridement with the imaging device.
• The potential subject has adequate off-loading of the ulcer.

You may not qualify if:

• The potential subject is known to have a life expectancy of \< 3 months.
• The potential subject's target ulcer is not a pressure ulcer.
• The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• There is undermining at the wound edge or tunnelling.
• There is evidence of osteomyelitis complicating the target ulcer.
• The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit(For diabetics only).
• The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
• The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
• The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
• The potential subject has end stage renal disease requiring dialysis.
• The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
• The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.

Sponsors & Collaborators

• Applied Biologics, LLC: lead
• SerenaGroup, Inc.: collaborator

Study Sites (1)

Serena Group- Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Bennett Sarver

CONTACT

1-833-865-6300; info@serenagroups.com

Thomas Serena, MD

CONTACT

1-833-865-6300; info@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: It is a prospective multicenter controlled clinical trial using matched controls.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)