Amniotic Membrane for Bed Sores

Overseen By Bennett Sarver

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Applied Biologics, LLC

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy, Biologics

Disqualifiers: Pregnancy, Osteomyelitis, End stage renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 20 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for bed sores, also known as pressure ulcers, using a single-layer amniotic membrane called XPURT. The trial aims to determine if combining XPURT with standard care methods, such as cleaning and protecting the sore, improves healing compared to standard care alone. It seeks participants who have had a serious pressure ulcer on their back or hips for over a month. Eligible participants should have a sore that is not infected and falls within a certain size range. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressants, certain chemotherapy drugs, or medications that might interfere with wound healing. It's best to discuss your specific medications with the trial team.

What is the safety track record for XPURT?

Research shows that treatments using amniotic membranes, such as XPURT, are generally well-tolerated. In past studies, amniotic membranes have helped heal wounds, reduce pain, and improve healing in chronic wounds. These studies suggest that XPURT should have few side effects.

XPURT is currently in a Phase 4 trial, indicating it has already passed earlier trials assessing its safety. Phase 4 trials typically examine long-term effects and specific conditions. Testing XPURT at this stage suggests it is likely safe for people. However, monitoring for any unexpected reactions to a treatment remains important.

Overall, using XPURT alongside standard care for pressure ulcers appears promising in terms of safety, with a history of being well-received in similar treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about XPURT for treating bed sores because it uses a single-layer amniotic membrane, which is not part of the standard care. Unlike traditional treatments that focus on debridement, off-loading, and specialized dressings, XPURT introduces biological materials that may promote faster healing and tissue regeneration. This innovative approach targets the underlying healing process, potentially offering quicker and more effective relief for patients with bed sores.

What evidence suggests that XPURT might be an effective treatment for bed sores?

Research has shown that treatments using amniotic membranes, such as XPURT, may aid in healing difficult bed sores. Participants in this trial will receive either standard care alone or XPURT combined with standard care. One study found that using a human amniotic membrane resulted in over 90% of ulcers healing completely, compared to standard care. XPURT, a single-layer amniotic membrane, is being tested to determine if it can accelerate healing when used with regular wound care. Earlier research suggests that amniotic membranes can speed up wound healing. This treatment has already received approval for use, indicating effectiveness for some conditions. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with nonhealing pressure ulcers, commonly known as bedsores. Participants should be suitable for standard care treatments and willing to potentially receive an additional treatment involving a single-layer amniotic membrane (XPURT).

Inclusion Criteria

I am 18 years old or older.

I have a severe pressure ulcer on my trunk that has lasted for at least a month.

I am willing and able to give my consent to participate.

Exclusion Criteria

My wound is complicated by a bone infection.

Subject is known to have a life expectancy of less than 3 months

Subject's target ulcer is not a pressure ulcer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly applications of XPURT + SOC for up to 20 weeks or until complete ulcer closure

20 weeks

Weekly visits (in-person)

Closure Confirmation

Ulcer closure is confirmed 2 weeks after initial assessment of 100% closure

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XPURT

Trial Overview The study is testing the effectiveness of adding a single-layer amniotic membrane (XPURT) to the usual wound care practices in treating nonhealing pressure ulcers compared to patients who only receive standard care.

How Is the Trial Designed?

Group I: XPURT + SOC Experimental Treatment 1 Intervention

Single-layer amniotic membrane plus standard of care.

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Applied Biologics, LLC

Lead Sponsor

Trials

3

Recruited

700+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223281

Study Details | NCT07223281 | Real-World Effectiveness of ... Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and ...

2. withpower.com withpower.com/trial/phase-4-pressure-ulcer-5-2025-b345d

Amniotic Membrane for Bed Sores Trial Overview The study is testing the effectiveness of adding a single-layer amniotic membrane (XPURT) to the usual wound care practices in treating ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11032220/

Assessing the Application and Effectiveness of Human ... Findings revealed that HAM treatment significantly accelerated ulcer closure, demonstrating over 90% complete healing compared to standard care.

4. mdpi.com mdpi.com/2571-841X/8/4/199

Clinical Experience Using a Dual-Layer Amniotic ... Conclusions: Results suggest that the application of dual-layer allografts in the context of chronic ulcers may represent a safe and effective wound management ...

5. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/freshly-collected-amniotic-membrane-therapy-in-chronic-non-healing-ulcers-a-regenerative-approach-to-wound-healing-mechanisms-and-vascular-regeneration-4171/

Freshly Collected Amniotic Membrane Therapy in Chronic ... Conclusion: Fresh human amniotic membrane significantly improved healing outcomes in non-healing ulcer patients compared to conventional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07126886

Study Details | NCT07126886 | A Multicenter, Prospective, ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316762/

Amniotic Membrane Transplantation for Wound Healing ... This review comprehensively evaluates AMT's efficacy in acute and chronic wound management, where it has been shown to alleviate pain, reduce ...

8. patlynk.com patlynk.com/trial/NCT07126886

Amniotic Membrane for Nonhealing Pressure Ulcers 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.