Dehydrated Human Amnion Membrane for Foot Ulcer

Overseen By Bennett M Rogers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Axolotl Biologix

Must not be taking: Immunosuppressants, Chemotherapy, Steroids

Disqualifiers: Infection, Osteomyelitis, Charcot foot, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dehydrated human amnion membrane (dhAM) can heal diabetic foot ulcers more effectively than standard care alone. Diabetic foot ulcers are wounds that heal poorly and require additional intervention. Participants will receive either standard care, which includes cleaning and bandaging, or standard care plus the special treatment. The trial seeks individuals with type 1 or 2 diabetes who have had a foot ulcer for 4 to 52 weeks that hasn't healed with usual treatment. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or high doses of corticosteroids, you may not be eligible to participate.

What prior data suggests that the dehydrated human amnion membrane is safe for treating diabetic foot ulcers?

Research has shown that the Axolotl DualGraft, made from dried human amnion membrane, is safe for treating foot ulcers. Studies have found no negative side effects when applying this treatment to wounds. It has been used successfully alongside regular care for diabetic foot ulcers and other chronic wounds, indicating that patients generally accept the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard care for foot ulcers, which involves cleaning, debridement, managing moisture, and relieving pressure, Axolotl DualGraft offers a unique approach by using dehydrated human amnion membrane. This treatment is derived from the innermost layer of the placenta and is believed to enhance healing by providing a natural scaffold that supports cell growth and tissue regeneration. Researchers are excited about it because it could potentially speed up recovery times and improve healing outcomes compared to traditional methods.

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

Research has shown that dehydrated human amnion membrane (dhAM), which participants in this trial may receive as part of the Axolotl DualGraft + SOC treatment arm, can significantly aid in healing diabetic foot ulcers. Patients treated with this membrane, alongside standard care, healed more than twice as fast as those who received only standard care. The amniotic membrane has successfully treated various chronic wounds, not just diabetic foot ulcers. It acts like a natural bandage, promoting faster healing by protecting wounds and reducing swelling. The evidence is promising for dhAM as an effective treatment for non-healing foot ulcers. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 1 or 2 diabetes who have a nonhealing foot ulcer between 1.0 and 5.0 cm², present for at least four weeks but no more than one year. The ulcer should be on the foot below the ankle and not expose tendon or bone. Participants must meet specific blood flow criteria to ensure proper wound healing.

Inclusion Criteria

The subject must be willing and able to participate in the informed consent process

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

My foot ulcer is deep but doesn't show tendon or bone.

Exclusion Criteria

My ulcer has not shrunk by 20% or more in the last 2 weeks.

A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA)

I haven't used steroid creams on my ulcer in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dehydrated human amnion membrane (dhAM) and standard of care (SOC) or SOC alone for the treatment of nonhealing diabetic foot ulcers

12 weeks

Visits at TV1, TV3, TV7, TV11, and TV12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Axolotl DualGraft + SOC
• Dehydrated Human Amnion Membrane

Trial Overview The study aims to see if adding dehydrated human amnion membrane (dhAM) to standard care helps heal diabetic foot ulcers better than standard care alone. Patients will receive either the dhAM treatment plus regular wound care or just the usual wound care.

How Is the Trial Designed?

Group I: Axolotl DualGraft + SOC Experimental Treatment 1 Intervention

Axolotl DualGraft is a dehydrated human amnion membrane.

Group II: Standard of Care Active Control 1 Intervention

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Who Is Running the Clinical Trial?

Axolotl Biologix

Lead Sponsor

Trials

2

Recruited

110+

SerenaGroup, Inc.

Collaborator

Trials

32

Recruited

3,900+

Published Research Related to This Trial

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]

The use of amniotic membrane for treating diabetic foot ulcers (DFUs) significantly increased the rate of wound healing, with patients healing 2.32 times more often and 32 days faster compared to those using conventional dressings, based on a meta-analysis of six clinical trials involving 331 patients.

While the amniotic membrane showed promising results in terms of healing speed and frequency, there was no statistical evidence to suggest it was more effective than other conventional dressings, indicating that further research is needed to fully establish its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. Paggiaro, AO., Menezes, AG., Ferrassi, AD., et al.[2023]

The human acellular amniotic membrane (HAAM) was found to be effective in treating venous lower limb ulcers, with complete healing in 2 out of 4 patients and significant reductions in ulcer size and depth in all cases.

HAAM treatment not only led to improved healing outcomes, such as >50% granulation tissue formation and the disappearance of infection signs, but it also proved to be more cost-effective compared to traditional treatments like skin autografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human acellular amniotic membrane is adopted to treat venous ulcers. Wu, Z., Liu, X., Yuan, D., et al.[2020]

In a study involving 29 adults with diabetes and chronic foot ulcers, the use of dehydrated amniotic membrane allograft (DAMA) combined with standard care led to a significant increase in complete wound closure rates, with 35% achieving closure compared to 0% in the standard care group within 6 weeks.

No treatment-related adverse events were reported, indicating that DAMA is a safe option for managing diabetic foot ulcers, although further research is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Snyder, RJ., Shimozaki, K., Tallis, A., et al.[2017]

In a study of 11 patients with chronic diabetic foot ulcers (DFUs) who did not heal with standard care, the addition of dehydrated human amniotic membrane (dHAM) treatment led to a significant increase in healing rates, with 91% achieving complete healing by 12 weeks.

Patients treated with dHAM showed an average wound size reduction of 87.6% after 4 weeks, compared to only 26.8% with standard care alone, indicating that dHAM can greatly enhance healing outcomes for difficult-to-treat DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. Zelen, CM.[2022]

In a case series of five patients with chronic non-healing wounds, the use of dehydrated human amnion/chorion membrane allograft resulted in a significant mean area reduction of 43% at 3 weeks, with complete healing achieved in a median time of 64 days.

The treatment was safe, with no adverse events reported, and was easy to administer, indicating that dehydrated amnion/chorion membrane allograft could be an effective option for patients whose wounds have not responded to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. Mrugala, A., Sui, A., Plummer, M., et al.[2021]

Amniotic membrane transplantation showed promising results in treating refractory chronic leg ulcers, with complete re-epithelialization achieved in one case by week 8 and an average wound size reduction of 81.93% by week 16 across four ulcers.

The treatment also significantly reduced pain intensity by 86.6% without any observed adverse effects, suggesting it is a safe and effective alternative for patients with difficult-to-treat ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane transplantation in the treatment of chronic lower limb ulcers. Alsina-Gibert, M., Pedregosa-Fauste, S.[2012]

In a retrospective case series, dehydrated human amniotic membrane (dHAM) allografts were applied to chronic wounds that had not responded to traditional treatments, showing improved healing outcomes over a 1-month period.

The use of dHAM allografts changed the healing trajectory of these wounds, suggesting that they could be a valuable addition to current wound care therapies, warranting further clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series. Forbes, J., Fetterolf, DE.[2014]

Citations

1. withpower.com withpower.com/trial/phase-diabetic-foot-ulcers-dfus-7-2024-959ea

Dehydrated Human Amnion Membrane for Foot Ulcer The use of amniotic membrane for treating diabetic foot ulcers (DFUs) significantly increased the rate of wound healing, with patients healing 2.32 times more ...

2. acquaintpublications.com acquaintpublications.com/article/amniotic_membrane_and_amnion_conditioned_media_promote_chronic_wound_healing_a_case_report

Amniotic Membrane and Amnion-Conditioned Media ... Allogeneic amniotic membrane has been used successfully in conjunction with SOC for treating diabetic foot ulcers, chronic vein ulcers [22-27,36,37], and ...

3. ctv.veeva.com ctv.veeva.com/study/dehydrated-human-amnion-membrane-and-standard-of-care-versus-standard-of-care-alone-in-nonhealing-di

Dehydrated Human Amnion Membrane and Standard of Care ... The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06550596/dehydrated-human-amnion-membrane-and-standard-of-care-versus-standard-of-care-alone-in-nonhealing-diabetic-foot-ulcers

Dehydrated Human Amnion Membrane and Standard of ... The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone ...

5. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/skin-soft-tissue-substitutes-08012025.pdf

Skin and Soft Tissue Substitutes Human amniotic membrane was used in all studies rather than synthetic types. Diabetes was the primary cause of the ulcer. The ulcers had a mean ...

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

Human amniotic membrane products for patients with ... The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised ...

7. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=39865

Skin Substitute Grafts/Cellular and Tissue-Based Products ... This LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in ...