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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Amnio-Maxx to see if it aids in healing diabetic foot ulcers when combined with standard care. The goal is to determine if this treatment improves healing for individuals with difficult-to-treat ulcers. Participants should have a diabetic foot ulcer that hasn't significantly healed in the past two weeks despite standard treatment. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from innovative treatment.

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 prior data suggests that Amnio-Maxx is safe for use in patients with diabetic foot ulcers?

Research has shown that Amnio-Maxx, a treatment using amniotic membrane, is generally safe for people with diabetic foot ulcers. Studies indicate no major differences in negative side effects compared to other treatments, meaning serious side effects are rare.

Although detailed data remains limited, the treatment has been used in other studies for similar conditions with a good safety record. For those considering joining a trial with Amnio-Maxx, current evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Amnio-Maxx is unique because it incorporates amniotic membrane technology, which is not typical in standard treatments for foot ulcers. While most treatments focus on debridement, offloading, and maintaining moisture balance to promote healing, Amnio-Maxx offers a new approach by potentially enhancing tissue regeneration and reducing inflammation. Researchers are excited about this treatment because it might accelerate healing and improve outcomes for patients with foot ulcers, offering a promising alternative to existing care methods.

What evidence suggests that Amnio-Maxx is effective for diabetic foot ulcers?

Research has shown that treatments using amniotic membrane, such as Amnio-Maxx, can aid in healing diabetic foot ulcers. In this trial, some participants will receive Amnio-Maxx alongside standard care. One study found that 69% of wounds treated with Amnio-Maxx healed completely in 12 weeks, compared to 47% with standard care alone. These findings suggest that Amnio-Maxx might accelerate healing for persistent foot ulcers. Another study supports the use of similar products, demonstrating improved healing rates. The evidence indicates that Amnio-Maxx could be a promising addition to standard foot ulcer treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Marissa Docter, RN, BSN, MD

Principal Investigator

Capsicure, LLC

Windy Cole, DPM

Principal Investigator

Capsicure, LLC

Are You a Good Fit for This Trial?

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 willing and able to follow the study's requirements.

I have signed the informed consent form.

My foot has good blood flow as shown by specific tests.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07209475

Study Details | NCT07209475 | Effect of Amnio-Maxx on ...

A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers. Conditions.

2.

pmc.ncbi.nlm.nih.gov

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

Human amniotic membrane products for patients with ...

The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial.

3.

withpower.com

withpower.com/trial/phase-diabetic-foot-8-2024-a8731

Amnio-Maxx for Foot Ulcer

Research shows that treatments using amniotic membrane, similar to Amnio-Maxx, have been effective in healing diabetic foot ulcers. Studies found that these ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/84ffa82cb1a95b3b/nct07209475-amnio-maxx-chronic-diabetic-foot-ulcers

Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic ...

This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic ...

5.

genesispub.org

genesispub.org/accelerated-healing-of-diabetic-and-venous-ulcers-with-adjunctive-dehydrated-human-amniotic-membrane-a-real-world-retrospective-cohort-study-from-a-single-provider-practice

Accelerated Healing of Diabetic and Venous Ulcers with ...

Overall, 69% of wounds treated per protocol with Sanoplast® DHAAM completely healed within 12 weeks of treatment compared to 47% in the SOC ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11505069/

Management of Foot Ulcers and Chronic Wounds with ...

The paired t-test showed a significant reduction in wound size from baseline to the end of the treatment (p < 0.01). Four patients achieved 100% ...

7.

jfootankleres.biomedcentral.com

jfootankleres.biomedcentral.com/articles/10.1186/s13047-022-00575-y

Human amniotic membrane products for patients with diabetic ...

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: Results of a multi-centre, controlled, randomised, blinded ...