Amnio-Maxx for Foot Ulcer

Recruiting at 11 trial locations

Overseen By Marissa Docter, RN, BSN, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Capsicure, LLC

Must be taking: Oral glycemic, Insulin

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids

Disqualifiers: Cancer, Cardiovascular, Renal, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, certain chemotherapy, or topical steroids, you may need to stop these before joining the trial.

What data supports the effectiveness of the treatment Amnio-Maxx for foot ulcers?

Research shows that treatments using amniotic membrane, similar to Amnio-Maxx, have been effective in healing diabetic foot ulcers. Studies found that these treatments can speed up wound healing and improve the chances of ulcers closing compared to standard care alone. ^{1 2 3 4 5}

Is Amnio-Maxx safe for use in humans?

Studies on amniotic membrane treatments, like Amnio-Maxx, for diabetic foot ulcers show they are generally safe, with no significant difference in adverse events compared to standard care. ^{3 4 5 6 7}

How does the Amnio-Maxx treatment for foot ulcers differ from other treatments?

Amnio-Maxx is unique because it uses a dehydrated amniotic membrane, which is a type of biological dressing derived from the human placenta, to help heal foot ulcers. This treatment is different from standard care as it aims to accelerate wound healing by providing a natural scaffold that supports tissue regeneration. ^{1 3 4 5 8}

Research Team

Windy Cole, DPM

Principal Investigator

Capsicure, LLC

Marissa Docter, RN, BSN, MD

Principal Investigator

Capsicure, LLC

Eligibility Criteria

This trial is for adults over 18, with Type I or II Diabetes Mellitus and a diabetic foot ulcer present for more than 4 weeks but less than a year. The ulcer should be between 2.0 cm² and 25 cm² in size after cleaning, not healing well, and have adequate blood flow to the foot. People over 65 are especially encouraged to join.

Inclusion Criteria

I am 18 or older, and I understand the study aims to enroll many people over 65.

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

I have signed the informed consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants complete a 2-week run-in period prior to treatment allocation

2 weeks

Treatment

Participants receive Amnio-Maxx and standard of care or standard of care alone for 12 weeks

12 weeks

Weekly visits (± 3 days), additional visits as needed for dressing changes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Amnio-Maxx

Trial Overview The study tests Amnio-Maxx as an additional treatment for diabetic foot ulcers that haven't improved with standard care alone. It's a randomized controlled trial, meaning participants will be randomly assigned to receive either Amnio-Maxx or continue only with their current treatment.

Participant Groups

Group I: Amnio-Maxx as an addition to standard of care Experimental Treatment 1 Intervention

Device exposure is estimated to be a maximum of 12 weeks

Group II: No intervention: Standard of Care Active Control 1 Intervention

Debridement, offloading, and proper moisture balance dressings

Who Is Running the Clinical Trial?

Capsicure, LLC

Lead Sponsor

Trials

2

Recruited

300+

Findings from Research

A clinical trial involving 92 type 2 diabetic patients demonstrated that a gel made from amniotic fluid significantly improved wound healing in diabetic foot ulcers compared to a placebo, with notable differences in wound grade and healing duration after eight weeks.

The study suggests that amniotic fluid gel is a safe and effective treatment option for chronic diabetic foot ulcers, highlighting its potential as a beneficial therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of a gel made with amniotic fluid formulation on the healing of diabetic foot ulcers: A triple-blind clinical trial. Niami, F., Molavynejad, S., Hemmati, AA., et al.[2023]

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 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]

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 pilot trial involving 31 participants with diabetic foot ulcers, the addition of dried human amniotic membrane (dHAM) to standard care showed a higher healing rate (27%) compared to standard care alone (6.3%) within 12 weeks, although the difference was not statistically significant (P = .1).

The dHAM group also demonstrated a significantly greater percentage reduction in wound area (P = .0057) with no difference in adverse events between the two groups, indicating that dHAM is a safe and potentially effective treatment for diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study. Game, F., Gray, K., Davis, D., et al.[2021]

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]

In a randomized controlled trial involving 76 diabetic foot ulcers, hypothermically stored amniotic membrane (HSAM) significantly improved wound closure rates compared to standard of care, with 60% closure at week 12 and 63% at week 16.

HSAM also resulted in greater reductions in both the area and depth of the ulcers, showing over 60% reduction in area and 65% in depth, indicating its effectiveness in promoting healing in diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. Serena, TE., Yaakov, R., Moore, S., et al.[2020]

Fetal membranes, specifically amnion and chorion, can be effectively used as biological dressings for treating various types of lower extremity ulcers, as demonstrated through multiple case histories.

The authors advocate for the broader adoption of fetal membranes in clinical practice, highlighting their potential benefits in enhancing healing for pedal ulcerations encountered by podiatrists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications for the use of amnion and chorion in podiatric medicine and surgery. Boc, SF., Chairman, EL., Freed, EL.[2009]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of a gel made with amniotic fluid formulation on the healing of diabetic foot ulcers: A triple-blind clinical trial. [2023]

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

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

3. 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]

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. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study. [2021]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. [2020]

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

Implications for the use of amnion and chorion in podiatric medicine and surgery. [2009]