Amniotic Membrane Allograft for Foot Ulcer

(REBOUND Trial)

Overseen By Christopher Schultz, BS, CCRA, ACRP-PM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Legacy Medical Consultants

Must not be taking: Immunosuppressants, Chemotherapy, COX-2 inhibitors, others

Disqualifiers: Cancer, Osteomyelitis, Poor metabolic control, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding an amniotic membrane allograft (a type of tissue graft) to standard care can more effectively heal diabetic foot ulcers. Researchers aim to determine if this additional treatment speeds up wound closure after 12 weeks compared to standard care alone. Individuals over 50, who have had a diabetic foot ulcer for at least four weeks, and are mobile may qualify for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot take certain medications like immunosuppressants, chemotherapy, or COX-2 inhibitors. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Orion™ Amniotic Membrane Allograft is safe for treating foot ulcers?

Research has shown that treatments using amniotic membrane allografts, such as Orion™, are generally safe for individuals with diabetic foot ulcers. One study found no major differences in side effects between patients who received the amniotic membrane treatment and those who did not, indicating that the treatment is well-tolerated and does not increase the risk of side effects.

Additionally, this treatment is tested alongside standard wound care, providing extra support without replacing the usual care routine. Participants in previous studies did not experience more complications when the amniotic membrane was added. This information may reassure those considering joining a clinical trial that the treatment is safe based on prior research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for diabetic foot ulcers, which typically involves cleaning, debridement, and dressings, the Orion™ Amniotic Membrane Allograft introduces a novel approach by using an amniotic membrane. This membrane is believed to have unique healing properties, including anti-inflammatory and anti-scarring effects, which can potentially accelerate the healing process. Researchers are excited about this treatment because it could offer a more efficient and effective way to heal foot ulcers, reducing recovery time and improving patient outcomes compared to current methods.

What evidence suggests that the Orion™ amniotic membrane allograft is effective for diabetic foot ulcers?

Research has shown that amniotic membrane allografts, such as Orion™, can aid in healing diabetic foot ulcers. One study demonstrated that patients treated with this membrane experienced a 50% reduction in wound size within 4 weeks. Another study found that a similar product, EPIFIX, also significantly improved healing in patients with these ulcers. In this trial, participants will receive either the standard care for diabetic foot ulcer wound management or the standard care plus the Orion™ amniotic membrane allograft. This evidence suggests that adding the Orion™ allograft to regular wound care might enhance healing. The treatment appears promising for accelerating wound closure and reducing complications. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people aged 50-85 with diabetic foot ulcers that have been present for at least 4 weeks but less than a year. Participants must be able to give consent, follow the study's procedures, and have ulcers that are between certain sizes. They should not have other close wounds and must meet specific blood flow and oxygen measurements in their feet.

Inclusion Criteria

I am between 50 and 85 years old.

I am willing and able to agree to participate in the study.

I am willing and able to follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly application of Orion™ amniotic membrane allograft in addition to standard wound care for diabetic foot ulcers

12 weeks

12 visits (in-person, weekly)

Follow-up

Participants are monitored for recurrence of ulcers and adverse events

6 months

Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Orion™ Amniotic Membrane Allograft

Trial Overview

Researchers are testing if adding Orion™ amniotic membrane allograft to standard wound care helps heal diabetic foot ulcers better over a period of 12 weeks. Patients will receive either the standard treatment or the standard plus Orion™, attending weekly doctor visits and completing quality of life questionnaires.

How Is the Trial Designed?

Group I: Amniotic Membrane plus Standard of Care Experimental Treatment 2 Interventions

Weekly application of Orion™ amniotic membrane allograft in addition to standard of care DFU wound management

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

Standard of care DFU wound management

Who Is Running the Clinical Trial?

Legacy Medical Consultants

Lead Sponsor

Trials

1

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12624360/

Effectivity of the Dehydrated Human Amnion/Chorion ...

This study investigated the efficacy of EPIFIX for diabetic foot ulcers in Japan. This study included 55 patients who were treated with EPIFIX ...

3.

internationaljournaloftissuerepair.com

internationaljournaloftissuerepair.com/index.php/ijtr/article/download/29/50/324

Real world evidence retrospective study to evaluate the ...

Aims: To evaluate the reduction of LEDU wound size after amniotic membrane allograft (AmnioBurgeon (OneBiotech, LLC,. USA) treatment.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06420245

Clinical Utility of an Amniotic Membrane Allograft for ...

The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can ...

5.

ctv.veeva.com

ctv.veeva.com/study/rct-to-demonstrate-the-clinical-utility-of-an-amniotic-membrane-for-the-management-of-diabetic-foot

Clinical Utility of an Amniotic Membrane Allograft for Diabetic ...

The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12678873/

A Multi‐Centre, Randomised, Controlled Clinical Trial ...

While there were no significant differences in healing rates or adverse events between the two treatment arms at any time point, this study ...