XWRAP for Diabetic Foot Ulcers

Overseen By Thomas Serena, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Applied Biologics, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Biologics, others

Disqualifiers: Infection, Osteomyelitis, Pregnancy, 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: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called XWRAP for individuals with stubborn diabetic foot ulcers that resist healing. The researchers aim to determine if a special placental-based allograft (a type of tissue graft) can enhance wound healing alongside usual care. Individuals with diabetes who have struggled with non-healing ulcers after participating in the CAMPX study might be suitable candidates. Participants must commit to weekly study visits and adhere to specific care instructions throughout the trial. As a Phase 4 trial, this research focuses on understanding how this FDA-approved treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications like immunosuppressants or high-dose corticosteroids, as they may interfere with wound healing.

What is the safety track record for XWRAP?

Research shows that XWRAP, a treatment made from placental tissue, is under study for healing diabetic foot ulcers. Previous studies have found that treatments like XWRAP are generally well-tolerated by patients, with only mild side effects reported, if any. Since this trial is in Phase 4, XWRAP has already received approval for use and passed earlier safety tests. This phase primarily examines any long-term effects in a larger group of people. So far, no major safety concerns have emerged for people with diabetic foot ulcers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for diabetic foot ulcers, which typically involve regular wound dressings and antibiotics, XWRAP introduces a novel approach by utilizing a single-layer amniotic membrane combined with standard care. This amniotic membrane is known for its anti-inflammatory properties and ability to promote healing, setting it apart from traditional methods. Researchers are excited about XWRAP because it has the potential to enhance healing rates and reduce recovery time for patients, offering a promising alternative to existing therapies.

What is the effectiveness track record for XWRAP in treating diabetic foot ulcers?

Research shows that XWRAP, a treatment made from placental tissue, effectively heals diabetic foot ulcers (DFUs). Studies have found XWRAP promising as a protective layer, helping wounds heal completely within 12 weeks. One study found that treatments like XWRAP lead to better healing than standard care alone. Although some studies have shown bias, most agree that treatments using amniotic tissue, like XWRAP, effectively treat DFUs. This treatment has already received approval for at least one condition, proving its effectiveness. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with nonhealing diabetic foot ulcers. Participants should have a specific type of chronic wound that hasn't improved with standard treatments. Details on who can join are not fully provided, so interested patients should inquire about the full inclusion and exclusion criteria.

Inclusion Criteria

If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study

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

Exclusion Criteria

The potential subject is known to have a life expectancy of < 6 months

The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments

The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single-layer amniotic membrane and standard of care for nonhealing diabetic foot ulcers

12 weeks

Weekly visits for wound assessment and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XWRAP

Trial Overview The study is testing XWRAP, a single layer placental-based allograft, alongside usual care to see if it's more effective in healing diabetic foot ulcers compared to standard treatment alone.

How Is the Trial Designed?

Group I: XWRAP Experimental Treatment 1 Intervention

Single-layer amniotic membrane + standard of care.

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. trial.medpath.com trial.medpath.com/clinical-trial/b9cc1a2dfdb19a49/nct06564831-randomized-controlled-trial-placental-allograft-diabetic-foot-ulcers

Evaluating the Efficacy of a Single Layer Placental-based ... XWRAP® is an allograft membrane derived from human amniotic tissue. Designed to act as a protective barrier, it is effective for DFUs, venous leg ulcers (VLUs), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07159282

Study Details | NCT07159282 | A Multicenter, Prospective, ... The percentage of target ulcers achieving complete wound closure in 12 weeks. 1-12 Weeks. Secondary Outcome Measures ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8210978/

Skin Substitutes for Adults With Diabetic Foot Ulcers and ... Of the 40 studies evaluated, all assessed the outcome of complete wound healing. Of those, 26 studies evaluated the effectiveness of dermal substitutes (Table 3) ...

4. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39864&ver=2

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This study concluded that the use of AlloPatch plus SOC is more effective in the treatment of DFU than with SOC alone. However, this study had high risk of bias ...

5. ohsu.edu ohsu.edu/sites/default/files/2024-04/OHSU-HS-Skin-and-Tissue-Substitutes.2.2024.pdf

Skin and Tissue Substitutes – Engineered Grafix Core and Grafix Prime are extracellular matrix containing growth factors for acute and chronic wounds, including diabetic foot ulcers and ...

6. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36377

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... Diabetic foot ulcers may affect up to 6% of Medicare beneficiaries with either Type I or Type II diabetes. Chronic wounds such as DFUs and VLUs impact patient ...

7. withpower.com withpower.com/trial/phase-4-foot-ulcer-7-2025-24145

XWRAP for Diabetic Foot Ulcers This Phase 4 medical study run by Applied Biologics, LLC is evaluating whether XWRAP will have tolerable side effects & efficacy for patients with Foot ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=39760

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.

9. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/oh/medicaid/policies/MCP-357-Skin-Substitutes-for-Chronic-Wound-Healing-Outpatient.pdf

Skin Substitutes for Chronic Wound Healing – Outpatient The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: Results of a prospective randomized trial.