Actively Recruiting
A Randomized Controlled Multicenter Trial Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers
Led by Royal Biologics · Updated on 2025-10-07
248
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a cellular, acellular, matrix-like product called Amnio-Maxx4 Dual Layer Amnion Patch alongside the Standard of Care (SOC) compared to SOC alone for closing nonhealing diabetic foot ulcers (DFUs). This Phase 4 randomized controlled trial focuses on adult patients with chronic DFUs to better understand how Amnio-Maxx may affect healing rates. Participants will receive either the Standard of Care, which includes cleansing, debridement, wound documentation, and off-loading, or the Standard of Care plus the application of the Amnio-Maxx Dual Layer Amnion Patch. The study uses random assignment without masking. Treatments are applied during study visits, and the ulcer is carefully monitored for closure and healing progress. During the 12-week trial, participants will undergo assessments including ulcer measurements to evaluate complete closure and percentage area reduction. Pain related to the ulcer will be tracked using the Numeric Pain Rating Scale. Researchers will also monitor adverse events throughout the study. Participants must follow treatment protocols and attend regular visits to support accurate evaluation of outcomes related to healing diabetic foot ulcers.
CONDITIONS
Brief Title
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, with at least 50% of participants over 65 years old
- History of Type I or II Diabetes Mellitus treated by a physician with oral medication and/or insulin
- Presence of a diabetic foot ulcer Wagner grade 1 or 2 at or below the medial malleolus
- Ulcer present for more than 4 weeks but less than 12 months if treated with active standard care
- Less than 20% healing observed in the two-week screening before randomization
- Ulcer size between 1.0 cm2 and 25 cm2 after debridement at first treatment visit
- Prior infection of the index ulcer or limb must be treated and controlled per IDSA Guidelines Grade 1
- Ability and willingness to follow protocol requirements
- Signed informed consent
- Adequate circulation to affected foot demonstrated by specific oxygen or perfusion measurements
- Negative pregnancy test for females of childbearing potential and willingness to use contraception during the study
- Ulcer offloaded with protocol-defined device for at least 14 days before randomization
- Ulcer has a clean base and is free of necrotic debris at treatment placement
You will not qualify if you...
- Life expectancy less than 1 year
- Ulcer present for more than 1 year
- Lack of adequate two-week data showing less than 20% area reduction
- Inability to comply with offloading device
- Conditions compromising ability to complete study or history of poor medical adherence
- Ulcers that are completely necrotic or fibrotic tissue
- Major uncontrolled medical disorders including serious cardiovascular, renal, liver, pulmonary disease, lupus, palliative care, or sickle cell anemia
- Current treatment for active malignant disease or history of malignancy within the ulcer
- Other conditions that may compromise safety as judged by the investigator
- Known allergies or contraindications to amniotic tissue membranes or Amnio-Maxx components
- Participation in another clinical trial involving investigational drugs or devices that interfere
- Ulcer area reduced by 20% or more after 2 weeks of standard care before randomization
- Pregnancy or breastfeeding
- Recent or anticipated use of immunosuppressants, cytotoxic chemotherapy, or topical steroids near the ulcer
- Prior treatment of the ulcer with tissue engineered or scaffold materials within 30 days before first treatment visit
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits during screening period
Duration - 12 weeks
Participants receive either the Amnio-Maxx® Dual Layer Amnion Patch or standard wound care including cleansing, debridement, wound documentation, and off-loading to promote healing of chronic diabetic foot ulcers.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 8 locations
1
Lion Heart Clinical Research
Burbank, California, United States, 91501
Actively Recruiting
2
Royal Research South
Miami, Florida, United States, 33150
Actively Recruiting
3
Denali Health Atlanta, LLC
Stone Mountain, Georgia, United States, 30083
Actively Recruiting
4
SerenaGroup Research Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
5
Suffolk Foot and Ankle
East Patchogue, New York, United States, 11772
Actively Recruiting
6
Wound Care of Tulsa
Tulsa, Oklahoma, United States, 74135
Actively Recruiting
7
VAST Clinical Research Carrollton Foot Center
Carrollton, Texas, United States, 75010
Actively Recruiting
8
Elite Foot & Ankle Associates
Spicewood, Texas, United States, 78669
Actively Recruiting
Research Team
N
Nicole Schrecngost
G
Greg Cosentino
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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