Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, with at least 50% of participants being over 65 years old
- History of Type I or Type II Diabetes Mellitus treated with oral medications and/or insulin
- Presence of diabetic foot ulcer Wagner grade 1 or 2 located at or below the medial malleolus
- Ulcer present for more than 4 weeks but less than 12 months if treated with active standard of care
- Less than 20% healing during a two-week screening period
- Ulcer size between 1.0 cm2 and 25 cm2 after debridement at first treatment visit
- Prior infection of ulcer or limb must be treated and controlled following IDSA Guidelines Grade 1
- Ability and willingness to follow the study protocol
- Signed informed consent
- Adequate circulation to affected foot demonstrated by TCOM, SPP, ABI, or TBI within 3 months
- Negative pregnancy test for females of childbearing potential and agreement to use contraception
- 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 product placement
You will not qualify if you...
- Life expectancy less than 1 year
- Ulcer present for more than 1 year
- Lack of adequate 2-week historical data showing less than 20% area reduction
- Unable to comply with offloading device
- Conditions or history compromising ability to complete study or poor adherence to medical treatment
- Ulcers completely necrotic or fibrotic tissue
- Major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care, or sickle cell anemia
- Currently treated for active malignant disease or history of malignancy within the ulcer
- Other conditions that may compromise safety as judged by Principal Investigator
- Known allergies or contraindications to amniotic tissue membranes or Amnio-Maxx components
- Participation in another clinical trial with investigational drug or device interfering with this study
- Ulcer area reduced by 20% or more after 2 weeks of standard care prior to randomization
- Pregnant or breastfeeding
- More than two weeks of immunosuppressant treatment or recent use of chemotherapy or topical steroids on ulcer
- Ulcer previously treated with tissue engineered or scaffold materials within 30 days before first treatment visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
G
Greg Cosentino
CONTACT
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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