Recruiting

Amniotic Membrane for Nonhealing Pressure Ulcers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Standard of Care

+ XPURT + SOC
Other
Who is being recruted

Pressure Ulcer
+1

+ Ulcer, Pressure
+ Pressure Wound
Over 18 Years
+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorApplied Biologics, LLC
Study ContactBennett Sarver
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 11, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to test a new treatment method for nonhealing pressure ulcers, which are stubborn wounds that don't easily heal and can cause significant discomfort and complications for affected individuals. The study involves the use of a single-layer amniotic membrane product called XPURT, combined with the standard care (SOC) typically provided for these ulcers. The trial is conducted across multiple centers, involving up to 100 participants from 30 different care providers. By comparing the healing progress of ulcers treated with XPURT and SOC against those treated with SOC alone, the study seeks to find more effective solutions for managing these challenging wounds. Participants in the trial receive weekly treatments, where XPURT is applied along with the standard care methods. Each ulcer is carefully monitored and assessed every week to track its healing progress. The study continues for up to 20 weeks or until the ulcer is completely closed, which is confirmed by a follow-up visit two weeks later. An additional weekly visit can be scheduled if needed, mainly for changing dressings. This process ensures that any improvements in healing can be accurately measured, and the study aims to determine whether XPURT can enhance the healing process compared to standard treatments alone.

Official TitleA Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers 
Principal SponsorApplied Biologics, LLC
Study ContactBennett Sarver
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pressure Ulcer
Ulcer, Pressure
Pressure Wound
Pressure Area
Criteria
6 inclusion criteria required to participate
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)

Show More Criteria

18 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Debridement, off-loading, reduction of bacterial burden, and proper moisture balance using dressings.
Group II
Experimental
Single-layer amniotic membrane plus standard of care.
Study Objectives
Primary Objectives

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

The time to healing of the target ulcers over 20 weeks.

Percentage wound area reduction from TV-1 to TV-21 measured weekly with digital photographic planimetry, using an Imaging Device, and physical examination.

The number of product- or procedure- related adverse events.

Change in pain in the target ulcer assessed from TV-1 to TV-21 using the VAS scale.

Change in quality-of-Life based on the FWS \[Time Frame: TV-1, TV-4, TV-8, TV-12, TV-16, and TV-20 / Final Visit.

Change in quality-of-Life based on the wQOL \[Time Frame: TV-1, TV-4, TV-8, TV-12, TV-16, and TV-20 / Final Visit.

Average number of grafts used.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Serena Group- MonroevilleMonroeville, United StatesSee the location
Recruiting
One Study Center