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

NCT07209475 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Amnio-Maxx®
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 8

Brief Summary

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 foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.

Conditions

Diabetic Foot Ulcer (DFU); Amnio-Maxx

Outcome Measures

Primary Outcomes (2)

• Complete Ulcer Closure

  12 weeks

• Expected percentage area reduction (PAR)

  12-weeks

Secondary Outcomes (2)

• Average percentage change from baseline in pain level related to the ulcer estimated from observed data using Numeric Pain Rating Scale (NPRS) and a Bayesian mixed effect model.

  12 weeks

• Adverse events (AE)

  12 weeks

Study Arms (2)

Standard of Care

EXPERIMENTAL

Cleansing, debridement, wound documentation, off-loading

Other: Standard of Care (Investigator Choice)

Amnio-Maxx® Dual Layer Amnion Patch

EXPERIMENTAL

Application of Amnio-Maxx® Dual Layer Amnion Patch

Biological: Amnio-Maxx® Dual Layer Amnion Patch; Other: Standard of Care (Investigator Choice)

Interventions

Amnio-Maxx® Dual Layer Amnion Patch BIOLOGICAL

Application of Amnio-Maxx® Dual Layer Amnion Patch

Amnio-Maxx® Dual Layer Amnion Patch

Standard of Care (Investigator Choice) OTHER

Cleansing, debridement, wound documentation, off-loading

Amnio-Maxx® Dual Layer Amnion Patch; 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:

• Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.
• The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \> 65 years of age.
• The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and/or insulin replacement therapy.
• Potential subjects have an ulcer characterized by the following:
• Presence of a diabetic foot ulcer 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 diabetic foot ulcer 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 1.0cm2 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 methods, 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 is free of necrotic debris at time of placement of treatment product.

You may not qualify if:

• The Subject has a known 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 standard of care 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

Sponsors & Collaborators

• Royal Biologics: lead

Study Sites (8)

Lion Heart Clinical Research

Burbank, California, 91501, United States

RECRUITING

Royal Research South

Miami, Florida, 33150, United States

RECRUITING

Denali Health Atlanta, LLC

Stone Mountain, Georgia, 30083, United States

RECRUITING

SerenaGroup Research Center

Omaha, Nebraska, 68114, United States

RECRUITING

Suffolk Foot and Ankle

East Patchogue, New York, 11772, United States

RECRUITING

Wound Care of Tulsa

Tulsa, Oklahoma, 74135, United States

RECRUITING

VAST Clinical Research Carrollton Foot Center

Carrollton, Texas, 75010, United States

RECRUITING

Elite Foot & Ankle Associates

Spicewood, Texas, 78669, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nicole Schrecngost

CONTACT

7246643843; nschrecengost@serenagroups.com

Greg Cosentino

CONTACT

5616850299; greg.cosentino@royalbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 7, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (8)