Perinatal Membrane Allografts for Diabetic Foot Ulcers

Overseen By Jerry Chang, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samaritan Biologics

Must not be taking: Immunosuppressants, Cytotoxic chemotherapy

Disqualifiers: Infection, Osteomyelitis, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether special tissue grafts from birth membranes, known as perinatal membrane allografts, can heal stubborn foot ulcers in people with diabetes. Researchers aim to determine if these grafts, when combined with regular wound care, lead to more ulcers healing completely within 12 weeks compared to regular care alone. Participants with diabetes who have had a foot ulcer for at least four weeks, but no longer than a year, may qualify for this study. Each participant will receive different treatments on their ulcers, and researchers will track healing progress with regular photos and measurements. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new healing methods for diabetic foot ulcers.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain steroids, you may be excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using two-layer donated tissue for diabetic foot ulcers is generally safe, with studies finding no major side effects linked to these tissues. Similarly, research on three-layer donated tissue with small openings indicates safety, with no significant side effects reported in treating foot ulcers. These findings suggest that both treatments are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for diabetic foot ulcers because they introduce perinatal tissue allografts, which are unlike traditional options such as cleansing, debridement, and dressings. These allografts are derived from placenta, offering a natural source of growth factors and extracellular matrix components that can accelerate healing. The dual-layer and three-layer fenestrated designs potentially enhance wound coverage and promote better integration with the body's tissues, which might lead to faster and more effective ulcer healing compared to standard care alone. This innovative approach could significantly improve outcomes for patients, reducing healing time and lowering the risk of complications.

What evidence suggests that this trial's treatments could be effective for diabetic foot ulcers?

Research has shown that perinatal membrane allografts can heal diabetic foot ulcers more effectively than standard treatments alone. For example, one study found that 46% of wounds treated with these allografts showed significant improvement by the fourth week. Made from placenta-derived materials, these allografts consistently achieve better ulcer healing. This trial studies both dual-layer and three-layer versions of these allografts as separate treatment arms to assess their potential in improving healing for these difficult-to-treat wounds. ^{3 6 7 8 9}

Who Is on the Research Team?

Thomas E Serena, MD

Principal Investigator

SerenaGroup, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 1 or 2 diabetes who have a chronic foot ulcer between the sizes of 1.0 cm² and 20.0 cm² that's been present for at least four weeks but no more than one year, located below the ankle without exposed tendon or bone.

Inclusion Criteria

I meet all the required criteria for the study enrollment.

I have been diagnosed with type 1 or type 2 diabetes.

My target ulcer is between 1.0 cm2 and 20.0 cm2 in size after cleaning.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive weekly applications of perinatal tissue allografts and standard of care wound management or standard of care alone

12 weeks

Weekly visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perinatal Membrane Allografts

Trial Overview The study tests if adding perinatal tissue allografts to standard wound care helps heal diabetic foot ulcers better than standard care alone. Participants will receive weekly treatments for their ulcers and complete questionnaires about their quality of life during the treatment period.

How Is the Trial Designed?

Group I: Three-layer fenestrated perinatal tissue allograft Experimental Treatment 2 Interventions

Patients will receive weekly applications of a three-layer fenestrated perinatal tissue allograft in addition to standard of care wound management.

Group II: Dual-layer perinatal tissue allograft Experimental Treatment 2 Interventions

Patients will receive weekly applications of a dual-layer perinatal tissue allograft in addition to standard of care wound management.

Group III: Standard of care (SOC) wound management Active Control 1 Intervention

Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.

Who Is Running the Clinical Trial?

Samaritan Biologics

Lead Sponsor

Trials

2

Recruited

170+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+

Serena Group

Collaborator

Trials

6

Recruited

790+

Serena Group

Collaborator

Trials

6

Recruited

790+

Published Research Related to This Trial

A fresh human placental membrane allograft was successfully used to heal a chronic venous ulcer in an 89-year-old woman, demonstrating its potential effectiveness in treating long-standing wounds.

After 60 days of treatment, the ulcer was completely healed, indicating that the amniochorionic membrane can be a viable therapeutic option for chronic vascular ulcers that do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft Piamo, A., García, M., Romero, D., et al.[2023]

Human amniotic membrane (HAM) allograft significantly improves the healing of chronic diabetic foot ulcers (DFUs), with a healing rate 3.88 times higher than standard care alone at 6 weeks and 2.01 times higher at 12 weeks, based on a meta-analysis of 7 studies involving 465 participants.

Patients receiving HAM treatment experienced a shorter time to complete healing by an average of 30.33 days, with no significant increase in adverse events, indicating that HAM is both effective and safe for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials. Su, YN., Zhao, DY., Li, YH., et al.[2021]

A review of 11 randomized controlled trials found that adding allogeneic skin substitutes and human placental membrane allografts to standard wound care significantly increases the healing rates of diabetic foot ulcers (DFUs) at 6 and 12 weeks.

One study suggested that placental membrane allografts may be more effective than allogeneic skin substitutes, but more research is needed to confirm this finding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Skin Substitutes Versus Human Placental Membrane Products in the Management of Diabetic Foot Ulcers: A Narrative Comparative Evaluation of the Literature. Luck, J., Rodi, T., Geierlehner, A., et al.[2019]

In a study of 63 patients with diabetes and chronic foot ulcers, 40% of the ulcers closed after 12 weeks of treatment with a chorioamniotic allograft, with smaller ulcers showing better closure rates (57% for small ulcers compared to 10% for large ulcers).

The treatment was found to be safe, with no unexpected adverse events reported, supporting its use as a wound cover for chronic foot ulcers in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. Pacaccio, DJ., Cazzell, SM., Halperin, GJ., et al.[2019]

The use of human amnion/chorion membrane in conjunction with standard therapy significantly improves healing rates for diabetic foot ulcers (DFUs), with a marked reduction in incomplete healing wounds compared to standard care alone, as shown in a meta-analysis of seven randomized controlled trials involving 352 initial studies.

Optimal assessment times for evaluating wound healing progress with amnion treatment are at 4 weeks and 12 weeks, indicating that early and later evaluations are crucial for understanding treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. Laurent, I., Astère, M., Wang, KR., et al.[2020]

In an open-label extension phase of a clinical trial involving 26 patients with chronic diabetic foot ulcers, 65.4% of patients achieved wound closure after receiving weekly applications of cryopreserved placental membrane (CPM) over a median of 34 days.

The use of CPM resulted in significantly fewer adverse events and wound-related infections compared to standard wound care, supporting its safety and efficacy as a treatment option for chronic diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane. Lavery, L., Fulmer, J., Shebetka, KA., et al.[2019]

The study focuses on diabetic patients with neuropathic foot ulcers, which are difficult to heal and can lead to severe complications like infections and amputations.

The new amniotic membrane-based allograft shows promise as a treatment option, potentially improving healing outcomes compared to traditional conservative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using amniotic membrane allografts in the treatment of neuropathic foot ulcers. Shah, AP.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32924804/

Use of a dual-layer amniotic membrane in the treatment ... Background: Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic ...

2. withpower.com withpower.com/trial/perinatal-membrane-allografts-for-diabetic-foot-ulcers-d7a5d

Perinatal Membrane Allografts for Diabetic Foot Ulcers Trial Overview The study tests if adding perinatal tissue allografts to standard wound care helps heal diabetic foot ulcers better than standard care alone.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1871402124002315

Placenta-derived biomaterials vs. standard care in chronic ... Placenta-derived biomaterials therapies have been shown to be more effective for achieving complete ulcer healing compared to current conventional treatments ...

4. researchgate.net researchgate.net/publication/397134561_Real_world_evidence_retrospective_study_to_evaluate_the_safety_and_efficacy_of_an_amniotic_membrane_allograft_for_lower_extremity_diabetic_ulcers_in_a_post-acute_care_setting

(PDF) Real world evidence retrospective study to evaluate ... By week 4, 46% of wounds achieved ≥50% reduction in their size. Conclusion: Amniotic membrane allograft is an effective treatment for LEDUs ...

5. mdpi.com mdpi.com/2571-841X/5/3/28

Application of Dehydrated Amniotic Membrane Allografts in ... This case study aims to report the efficacy of the application of dehydrated amniotic membrane allograft (DAMA) to a diabetic foot ulcer.

6. ctv.veeva.com ctv.veeva.com/study/evaluating-the-efficacy-of-perinatal-membrane-allografts-for-the-treatment-of-diabetic-foot-ulcers

Evaluating the Efficacy of Perinatal Membrane Allografts in ... The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41133540/

Clinical Experience Using a Dual-Layer Amniotic ... No adverse events or complications related to barreraTM were observed. Conclusions: Results suggest that the application of dual-layer ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11438271/

Preclinical and clinical evidence for using perinatal tissue ... Clinical studies have shown that patients who receive an intra-operative prostatic perinatal membrane wrap have faster return to potency and continence.

9. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/15347346241276697

Randomized Controlled Trial to Compare AmnioExcel ... RCTs have reported a higher incidence of healing with weekly compared to biweekly application of amnion allograft in diabetic foot ulcers.