Xcell Amnio Matrix for Foot Ulcers

Overseen By Kher Lee Ng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Horizon Medical Solutions

Must be taking: Insulin, Oral medications

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Infection, Dialysis, Cancer, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, Xcell Amnio MatrixTM (XAM), for individuals with diabetic foot ulcers. Researchers seek to determine whether adding XAM to standard care improves wound healing compared to standard care alone. Eligible participants should have a diabetic foot ulcer for at least four weeks that has not healed with standard treatment, located at or below the ankle. Participants will visit the clinic weekly for 12 weeks for treatment and monitoring. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

What prior data suggests that Xcell Amnio MatrixTM (XAM) is safe for treating foot ulcers?

Research shows that Xcell Amnio Matrix (XAM) has been safely used to treat various wounds, including diabetic foot ulcers. Studies indicate that XAM aids in healing persistent wounds such as foot ulcers, leg ulcers, and pressure sores. While specific safety details from trials are not provided, its use for many wound types suggests general safety.

Additionally, a review of similar skin treatments for diabetic foot ulcers supports their safety and effectiveness, implying that XAM might be similarly safe. These studies have not reported specific negative effects, indicating it is likely safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for foot ulcers, which typically involves dressings, debridement, and infection management, Xcell Amnio Matrix (XAM) offers a unique approach by using amniotic membrane technology. This treatment leverages the regenerative properties of the amniotic membrane, which is rich in growth factors that can accelerate healing. Researchers are excited about XAM because it has the potential to enhance tissue repair and reduce healing times, providing a new avenue for patients who suffer from chronic foot ulcers.

What evidence suggests that Xcell Amnio MatrixTM is effective for treating diabetic foot ulcers?

Research has shown that products made from the amniotic membrane, such as Xcell Amnio Matrix (XAM), can effectively heal diabetic foot ulcers (DFUs). In this trial, participants will receive either XAM combined with Standard of Care (SOC) or SOC alone. One study found that freeze-dried human amniotic membrane, when used with regular treatment, improved wound healing speed and effectiveness compared to regular treatment alone. Additionally, another review found that similar products accelerated healing and reduced treatment time more effectively than standard care. These findings suggest that XAM could be a promising option for faster healing of DFUs. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic non-healing diabetic foot ulcers (DFUs) that have lasted between 4 weeks and 1 year, are located at or below the ankle, and haven't responded to standard care. Participants must have diabetes managed by insulin or medication with HbA1c levels below 12%, and ulcers sized between 1.5cm2 and ≤20cm2 without reaching muscle, tendon, or bone.

Inclusion Criteria

My ulcer is between 1.5cm2 and 20cm2 in size and mostly clean.

I have diabetes and take insulin or other medications to manage it.

My ulcer has lasted more than 4 weeks but less than a year and hasn't healed with standard care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Re-screening

Participants are re-screened to confirm eligibility for the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive weekly applications of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care for 12 weeks

12 weeks

12 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Xcell Amnio MatrixTM (XAM)

Trial Overview

The study tests if adding Xcell Amnio MatrixTM (XAM) to regular wound care helps heal DFUs better than just the usual treatment. Patients will get weekly applications of XAM for 12 weeks and then be checked again after two more weeks to see how much their ulcer has healed.

How Is the Trial Designed?

Group I: Xcell Amnio MatrixTM (XAM) + Standard of Care (SOC) Experimental Treatment 1 Intervention

Group II: Standard of Care (SOC) Active Control 1 Intervention

Who Is Running the Clinical Trial?

New Horizon Medical Solutions

Lead Sponsor

Amarex Clinical Research

Collaborator

Trials

28

Recruited

1,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07116174?cond=Diabetes

A Prospective Clinical Study to Evaluate the Effectiveness ...

The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM ( ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/679238fc2a22d986/nct07116174-clinical-trial-xcell-amnio-matrix-wound-management

A Prospective Clinical Study to Evaluate the Effectiveness and ...

The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM ( ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9472416/

Human amniotic membrane products for patients with ...

The current review results support that DHACA with SOC has better efficacy than SOC alone in enhancing wound healing, reducing the mean time to ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07209475

Study Details | NCT07209475 | Effect of Amnio-Maxx on ...

Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization ...

5.

uhcprovider.com

uhcprovider.com/content/dam/provider/docs/public/policies/index/rmhp/skin-soft-tissue-substitutes-rmhp-04012025.pdf

Skin and Soft Tissue Substitutes – Rocky Mountain Health ...

Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials.

6.

nhmedical.com

nhmedical.com/products/xam/

XAM (Xcell Amnio Matrix™)

XAM is indicated for a wide range of chronic and acute wound types, including: Diabetic foot ulcers (DFUs); Venous leg ulcers (VLUs); Pressure ...

7.

precisebioscience.com

precisebioscience.com/products/xcell-amnio-matrix/

Xcell Amnio Matrix

Physicians have used Xcell to support wound closure of chronic diabetic foot ulcers, venous leg ulcers and pressure wounds. Surgical. Surgical application ...