ClinicalTrials.gg
Sign In
RecruitingNCT07126886Updated Oct 28, 2026

Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers

A Phase 4 interventional study of Standard of Care and XPURT + SOC in Pressure Ulcer, Ulcer, Pressure and Pressure Wound, sponsored by Applied Biologics, LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Applied Biologics, LLC · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Updated Oct 28, 2026Title changedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study is a multi-center, prospective, controlled clinical study consisting of 100 subjects from up to 30 providers. The subjects receive XPURT and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of XPURT + SOC for up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the XPURT arm or (2) change the standard of care dressing in the control arm.

02

Conditions studied

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

Browse trials for

03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Applied Biologics, LLC is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion 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 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.

Exclusion criteria

Exclusion Criteria:

  • The potential subject is known to have a 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 (including systemic 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 (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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Standard of Care

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

    Other: Standard of Care

  • Experimental
    XPURT + SOC

    Single-layer amniotic membrane plus standard of care.

    Other: XPURT + SOC

Interventions

  • OtherStandard of Care

    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.

  • OtherXPURT + SOC

    Participants will receive weekly applications of XPURT and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Complete Closure

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

    Time frame: 1-22 Weeks

Secondary outcomes

  1. Time to Healing

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

    Time frame: 1-22 Weeks

  2. Percentage of Wound Area Reduction

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

    Time frame: 1-22 Weeks

  3. Adverse Events

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

    Time frame: 1-22 Weeks

  4. Measure Pain

    0 to 10 scale where 0 is no pain and 10 is the worst imaginable pain using the VAS scale. Higher scores indicate worse pain

    Time frame: 1-22 Weeks

  5. Measure Quality of Life

    TV-1 to the final visit, measured with the Foot and Wound Status scale.

    Time frame: 1-22 Weeks

  6. Measure Quality of Life

    TV-1 to the final visit, measured with the wound-related Quality of Life instrument (wQOL).

    Time frame: 1-22 Weeks

  7. Average Product Usage

    Average number of grafts used.

    Time frame: 1-22 Weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Aug 2027, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Aug 17, 2025
StartActual
Jun 11, 2025
Primary completionEst.
Aug 2027
CompletionEst.
Aug 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
3 description edited
What changed in the outcomes
  • DescriptionMeasure Pain: how it is measured was reworded
  • DescriptionMeasure Quality of Life: how it is measured was reworded
  • DescriptionMeasure Quality of Life#2: how it is measured was reworded
Oct 28, 2026
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
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionMeasure Pain: how it is measured was reworded
    • DescriptionMeasure Quality of Life: how it is measured was reworded
    • DescriptionMeasure Quality of Life#2: how it is measured was reworded
    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

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07126886
Lead sponsor
Applied Biologics, LLC
Collaborators
SerenaGroup, Inc.
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Jun 11, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Bennett Sarver
Contact
info@serenagroups.com
1-833-865-6300
Thomas Serena, MD
Contact
info@serenagroups.com
1-833-865-6300

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pressure Ulcer →

Other studies from this sponsor

Applied Biologics, LLC

Start the discussion