Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Recruiting · Phase 4 · NCT07209475
Conditions: Diabetic Foot Ulcer (DFU), Amnio-Maxx
At a glance
- Research payments reported, 2025
- $548,680
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 248
About the trial
- Sponsor
- Royal Biologics
- Tested
- Amnio-Maxx® Dual Layer Amnion Patch (biological), Standard of Care (Investigator Choice) (other)
- Dates
- Started 2025-08-14; completion 2026-08-14
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2025-10-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Royal Biologics, Inc. reported $548,680 in research payments for this study in 2025 (38 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Minh Q. Mach, M.D. Specialist · Toluca Lake, CA
- Luis Aponte, MD Plastic Surgery · Tampa, FL
- Orlando A. Cedeno, D.P.M. Podiatrists · Jupiter, FL
- Imaze M. Davis, D.P.M Podiatrists · Miami, FL
- Melissa Perlman, DPM Podiatrists · Pembroke Pines, FL
- Theresa L. Harvey-gilliard, RN Nurse Practitioners · Lilburn, GA
- Stephanie Atoyebi, DPM Podiatrists · Melrose Park, IL
- Glenn P. York, DPM Podiatrists · Omaha, NE
- Edward C. Kormylo, DPM Podiatrists · East Patchogue, NY
- Lam Le, MD Internal Medicine · Tulsa, OK
- Naghmeh L. Khavari, DPM Podiatrists · Carrollton, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Suffolk Foot and Ankle $122,500
- The Clinical Trials Network, LLC $111,080
- Lion Heart Clinical Research $85,940
- Denali Health Plant City, LLC $67,450
- Royal Research South, Corp $38,290
- Wound Care of Tulsa $35,485
- Vast Clinical Reserach $32,535
- Denali Health Atlanta, LLC $21,995
- Pharmakon Medical Research $17,965
- Royal Research Corp $12,315
- Serenagroup Research Center Omaha $3,125
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.