Actively Recruiting
Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Led by Capsicure, LLC · Updated on 2025-04-30
150
Participants Needed
12
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers
CONDITIONS
Official Title
Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older, with at least half of the study group aged 65 or above
- History of Type I or Type II Diabetes requiring oral medication or insulin
- Presence of a Wagner grade 1 or 2 diabetic foot ulcer at or below the medial malleolus
- Ulcer duration between more than 4 weeks and less than 12 months with active standard of care treatment
- Less than 20% healing during a 2-week screening period before randomization
- Ulcer size between 1.0 cm2 and 25 cm2 after debridement at first treatment visit
- Prior infection on the ulcer or limb must be treated and controlled according to guidelines
- Ability and willingness to follow study protocol
- Signed informed consent
- Adequate blood flow to the affected foot demonstrated by specific measurements within 3 months of screening
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Ulcer offloaded with a defined device during the 2-week run-in period
- Ulcer base clean and free of necrotic tissue at treatment start
You will not qualify if you...
- Life expectancy less than 1 year
- Ulcer present for more than 1 year
- Insufficient data showing less than 20% area reduction in 2 weeks prior to randomization
- Unable to comply with offloading device use
- Conditions compromising ability to complete study or poor treatment adherence history
- Presence of completely necrotic or fibrotic ulcers
- Major uncontrolled medical disorders including serious heart, kidney, liver, lung diseases, lupus, palliative care, or sickle cell anemia
- Active cancer treatment or history of cancer at the ulcer site
- Any condition risking participant safety as judged by the investigator
- Known allergies to amniotic tissue or Amnio-Maxx components
- Participation in another interfering clinical trial
- Ulcer area reduced by 20% or more after 2 weeks of standard care
- Pregnancy or breastfeeding
- Recent or expected use of immunosuppressants or topical steroids on the ulcer
- Ulcer treated with tissue-engineered or scaffold materials within 30 days prior
- Need for hyperbaric oxygen treatment during or shortly before the study
- Poor diabetic metabolic control with HbA1c of 12.0 or higher
- Presence of gangrene or unstable ischemia in ulcer or limb
- Recent revascularization surgery on affected limb
- Ulcer suspected to be cancerous requiring biopsy
- Any significant clinical findings impacting health or study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
Actively Recruiting
2
North Park Podiatry
San Diego, California, United States, 92104
Actively Recruiting
3
Solutions Medical Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
4
Evolution Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
5
Symphony Research
Jacksonville, Florida, United States, 32257
Actively Recruiting
6
Quality Care Clinical Research
Miami, Florida, United States, 33142
Actively Recruiting
7
Medcentris
Hammond, Louisiana, United States, 70403
Actively Recruiting
8
Curalta Clinical Trials
Oradell, New Jersey, United States, 07649
Actively Recruiting
9
Suffolk Foot and Ankle
East Patchogue, New York, United States, 11772
Actively Recruiting
10
PA Foot and Ankle Associates
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
11
Stride Clinical Research
Houston, Texas, United States, 77027
Actively Recruiting
12
Ten20 Medical
Sunnyvale, Texas, United States, 75182
Actively Recruiting
Research Team
M
Marissa Docter, RN, BSN, MD
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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