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

NCT06572839 | Recruiting

• 1 other identifier: Med-Maxx
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Keywords

chronic ulcers; wound care; Dual Layer Amnion Patch

Outcome Measures

Primary Outcomes (2)

• Wound Closure Assessment Verified with Independent Adjudication

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

  12 weeks

• Percentage Area Reduction verified with Independent Adjudication

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

  12 weeks

Secondary Outcomes (2)

• Chage of Subjects Pain Levels

  12 weeks

• Change in Adverse Events

  12 weeks

Study Arms (2)

No intervention: Standard of Care

NO INTERVENTION

Debridement, offloading, and proper moisture balance dressings

Amnio-Maxx as an addition to standard of care

EXPERIMENTAL

Device exposure is estimated to be a maximum of 12 weeks

Other: Amnio-Maxx

Interventions

Amnio-Maxx OTHER

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

Also known as: Amnio-Maxx Dual Layer Amnion Allograft

Amnio-Maxx as an addition to standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• A. 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.
• B. 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Capsicure, LLC: lead

Study Sites (12)

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

RECRUITING

North Park Podiatry

San Diego, California, 92104, United States

RECRUITING

Solutions Medical Research

Coral Gables, Florida, 33134, United States

RECRUITING

Evolution Research Center

Hialeah, Florida, 33012, United States

RECRUITING

Symphony Research

Jacksonville, Florida, 32257, United States

RECRUITING

Quality Care Clinical Research

Miami, Florida, 33142, United States

RECRUITING

Medcentris

Hammond, Louisiana, 70403, United States

RECRUITING

Curalta Clinical Trials

Oradell, New Jersey, 07649, United States

RECRUITING

Suffolk Foot and Ankle

East Patchogue, New York, 11772, United States

RECRUITING

PA Foot and Ankle Associates

Allentown, Pennsylvania, 18104, United States

RECRUITING

Stride Clinical Research

Houston, Texas, 77027, United States

RECRUITING

Ten20 Medical

Sunnyvale, Texas, 75182, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Windy Cole, DPM

  Capsicure, LLC

  PRINCIPAL INVESTIGATOR

• Marissa Docter, RN, BSN, MD

  Capsicure, LLC

  STUDY DIRECTOR

Central Study Contacts

Marissa Docter, RN, BSN, MD

CONTACT

512-571-2966; mdocter@capsicure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The patient will be randomized to standard of care (SOC) or Amnio-Maxx as an addition to SOC

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: October 25, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)