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

Trial Summary

What is the purpose of this trial?

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 nonhealing diabetic foot ulcers (DFUs).

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 data supports the effectiveness of the treatment Axolotl DualGraft + SOC, Dehydrated Human Amnion Membrane for foot ulcers?

Research shows that dehydrated human amnion membrane can help heal chronic wounds, including diabetic foot ulcers, by significantly reducing wound size and improving healing time. In several studies, wounds treated with this membrane showed improved healing compared to traditional methods, suggesting it could be a beneficial addition to existing wound care therapies. ^{1 2 3 4 5}

Is dehydrated human amnion membrane safe for use in humans?

Studies on dehydrated human amnion membrane for treating foot ulcers and other wounds have shown it to be safe, with no reported adverse events in the cases reviewed. ^{1 4 5 6 7}

How is the treatment Dehydrated Human Amnion Membrane different from other treatments for foot ulcers?

Dehydrated Human Amnion Membrane is unique because it uses biological properties from the amniotic membrane to help heal foot ulcers, offering antimicrobial protection and promoting faster wound closure without causing an immune response. This treatment is particularly beneficial when traditional methods fail, making it a promising option for chronic wounds. ^{2 3 4 5 8}

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series. [2014]

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

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. [2017]

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

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

7. Greece pubmed.ncbi.nlm.nih.gov

Human acellular amniotic membrane is adopted to treat venous ulcers. [2020]

8. Spain pubmed.ncbi.nlm.nih.gov

Amniotic membrane transplantation in the treatment of chronic lower limb ulcers. [2012]