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

Part of paid clinical trials in Burbank, California.

Sponsor
Royal Biologics
Study ID
NCT07209475
Phase
PHASE4
Status
Recruiting
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Conditions

  • Amnio-Maxx
  • Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amnio-Maxx® Dual Layer Amnion Patch — BIOLOGICAL
    Application of Amnio-Maxx® Dual Layer Amnion Patch
  • Standard of Care (Investigator Choice) — OTHER
    Cleansing, debridement, wound documentation, off-loading

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Oct 2025
Primary completion
Aug 14, 2026
Completion
Aug 14, 2026

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of Care
    Cleansing, debridement, wound documentation, off-loading
  • Experimental: Amnio-Maxx® Dual Layer Amnion Patch
    Application of Amnio-Maxx® Dual Layer Amnion Patch

Primary Outcome Measure

Complete Ulcer Closure [ Time Frame: 12 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Lion Heart Clinical ResearchBurbankCalifornia91501
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
Royal Research SouthMiamiFlorida33150
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
Denali Health Atlanta, LLCStone MountainGeorgia30083
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
SerenaGroup Research CenterOmahaNebraska68114
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
Suffolk Foot and AnkleEast PatchogueNew York11772
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
Wound Care of TulsaTulsaOklahoma74135
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
VAST Clinical Research Carrollton Foot CenterCarrolltonTexas75010
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]
Elite Foot & Ankle AssociatesSpicewoodTexas78669
Nicole Schrecngost
[email protected]
7246643843
Greg Cosentino
[email protected]

Find similar trials in Burbank, CA

By research site
Lion Heart Clinical Research· Burbank, CARoyal Research South· Miami, FLDenali Health Atlanta, LLC· Stone Mountain, GASerenaGroup Research Center· Omaha, NESuffolk Foot and Ankle· East Patchogue, NYWound Care of Tulsa· Tulsa, OK

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