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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.

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.

What data supports the effectiveness of the treatment Perinatal Membrane Allografts for Diabetic Foot Ulcers?

Research shows that using human placental membrane allografts, which are similar to perinatal membrane allografts, can improve healing in diabetic foot ulcers. Studies found that these treatments help more ulcers heal completely within 6 to 12 weeks compared to standard care alone. ^{1 2 3 4 5}

Is the use of perinatal membrane allografts safe for treating diabetic foot ulcers?

Research shows that using human amniotic membrane allografts for diabetic foot ulcers is generally safe, with no significant difference in adverse events compared to standard care. ^{2 3 4 6 7}

How is the treatment using perinatal membrane allografts for diabetic foot ulcers different from other treatments?

This treatment uses a biological dressing made from the amniotic membrane, which contains nutrients and growth factors that help wounds heal faster. Unlike traditional dressings, it provides a natural environment that supports tissue repair and regeneration, making it a unique option for treating diabetic foot ulcers. ^{1 2 5 6 8}

Research Team

Thomas E Serena, MD

Principal Investigator

SerenaGroup, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2019]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Open-label Extension Phase of a Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Using Cryopreserved Placental Membrane. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis. [2022]

7. England 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. [2021]

8. Colombia pubmed.ncbi.nlm.nih.gov

Healing of a chronic ulcer of the lower limb of venous origin with fresh human amniochorionic membrane allograft [2023]