RECRUITING

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

Conditions

Pressure Ulcer Ulcer, Pressure Pressure Wound Pressure Area

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-11

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07126886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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. * The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. * The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. * The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.
* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
* The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
* The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.

Contacts and Locations

Study Contact

Bennett Sarver

CONTACT

888-960-1343

bsarver@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000

tserena@serenagroups.com

Study Locations (Sites)

Serena Group- Monroeville

Monroeville, Pennsylvania, 15146

United States

Collaborators and Investigators

Sponsor: Applied Biologics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-06-11

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Pressure Ulcer
Ulcer, Pressure
Pressure Wound
Pressure Area