AzTrials
AzTrials

Diabetic Foot UlcerNCT06572839

Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

A study testing Amnio-Maxx in people with Diabetic Foot Ulcer, run by Capsicure, LLC at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Amnio-Maxx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
12 sitesUnited States
Study dates
25 Oct 2024to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are 18 years of age or older. At least 50% of the enrolled population must be > 65 years of age.
  • Subject history of Type I or Type II Diabetes Mellitus requiring oral glycemic control and/or insulin replacement therapy.
  • Subjects with the following ulcer:
  • Presence of a DFU Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.
  • A DFU is present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
  • Objectively, less than 20% healing in the two-week screening period prior to randomization.
Show all 14Show fewer
  • Study ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 post-debridement at first treatment visit
  • Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
  • The subject is able and willing to follow the protocol requirements.
  • Subject has signed informed consent.
  • Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the first Screening Visit.
  • Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
  • The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1/Randomization).
  • The index ulcer has a clean base and free of necrotic debris at time of placement of treatment product.

Who cannot join

  • Subject has a documented life expectancy of < 1 year.
  • Index ulcer has been present for >1 year.
  • Patient does not have adequate 2-week historical data demonstrating < 20% area reduction.
  • Subject is unable to comply with offloading device.
  • Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
  • Subject has ulcers that are completely necrotic or fibrotic tissue.
Show all 21Show fewer
  • Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
  • Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
  • The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
  • Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.
  • Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
  • Index ulcer has reduced in area by 20% or more after 2 weeks of SOC from the first screening visit (S1) to the TV1/randomization visit.
  • Subject is pregnant or breastfeeding.
  • Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
  • Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
  • Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening treatment visit 1.
  • Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
  • Index ulcer and/or index limb with presence of, gangrene or unstable ischemia at screening (SV1).
  • Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
  • Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
  • Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • PA Foot and Ankle Associates

    Allentown, Pennsylvania, 18104

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Solutions Medical Research

    Coral Gables, Florida, 33134

  • Suffolk Foot and Ankle

    East Patchogue, New York, 11772

  • Medcentris

    Hammond, Louisiana, 70403

  • Evolution Research Center

    Hialeah, Florida, 33012

  • Stride Clinical Research

    Houston, Texas, 77027

  • Symphony Research

    Jacksonville, Florida, 32257

  • Quality Care Clinical Research

    Miami, Florida, 33142

  • Curalta Clinical Trials

    Oradell, New Jersey, 07649

  • North Park Podiatry

    San Diego, California, 92104

  • Ten20 Medical

    Sunnyvale, Texas, 75182

Other trials in United States

About this study

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

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

Read the detailed description

This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Amnio-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of these visits will be recorded. Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure. Additionally, pain and safety will be assessed as secondary endpoints.

Being tested
Amnio-Maxx
Keywords
chronic ulcers, wound care, Dual Layer Amnion Patch
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amnio-MaxxOther

    Also called Amnio-Maxx Dual Layer Amnion Allograft

    Amnio-Maxx Dual Layer Amnion Patch is processed using aseptic techniques, treated with a saline solution and dehydrated.

Study groups in NCT06572839
Study groupRoleWhat they receive
No intervention: Standard of CareNo interventionDebridement, offloading, and proper moisture balance dressings
Amnio-Maxx as an addition to standard of careExperimentalDevice exposure is estimated to be a maximum of 12 weeks
Receives: Other: Amnio-Maxx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Closure Assessment Verified with Independent Adjudication

    To demonstrate change in healing rates of chronic wounds (diabetic foot ulcers), unresponsive to standard therapy.

    Measured: 12 weeks

  2. Percentage Area Reduction verified with Independent Adjudication

    To demonstrate change in healing rates of chronic wounds (diabetic foot ulcers), unresponsive to standard therapy.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Chage of Subjects Pain Levels

    Subject pain assessed through the Numeric Pain Rating Scale on a weekly basis throughout the study

    Measured: 12 weeks

  2. Change in Adverse Events

    Change in Adverse Events estimated from the observed data through physician reporting

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start25 Oct 2024
  3. Primary completion1 May 2026
  4. Study completion1 May 2026

Why it stopped: Ended after interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patient will be randomized to standard of care (SOC) or Amnio-Maxx as an addition to SOC
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572839
Sponsor's protocol ID
Med-Maxx
Status last verified
May 2026
First submitted
23 Aug 2024
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.

Questions about this trial

What is this clinical trial studying?

A study testing Amnio-Maxx in people with Diabetic Foot Ulcer, run by Capsicure, LLC at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Ended after interim analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Closure Assessment Verified with Independent Adjudication (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in