Actively Recruiting
A Randomized Controlled Trial Examining the Effect of Miro3D Wound Matrix on Healing of Chronic Diabetic Foot Ulcers
Led by Reprise Biomedical, Inc. · Updated on 2026-06-08
180
Participants Needed
14
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the Miro3D Wound Matrix to standard care improves healing in adults with chronic diabetic foot ulcers. Diabetic foot ulcers are a serious complication of diabetes that may not heal well with usual treatment. This study compares healing outcomes between patients receiving Miro3D plus standard care and those receiving standard care alone, aiming to support wound healing and reduce complications such as infection and amputation. The trial enrolls about 180 adults with Wagner Grade 1 or 2 diabetic foot ulcers lasting between 4 weeks and 12 months. After a two-week screening period, participants are randomly assigned to one of two groups: one receiving Miro3D Wound Matrix applied topically to the ulcer along with standard care, and the other receiving standard care alone. Standard care includes sharp debridement, offloading with a device, and moisture-retentive dressings. Participants are followed weekly for up to 12 weeks. During each weekly visit, researchers assess wound size, take photographs, check for infection, and measure pain using a numeric scale. Safety is monitored throughout by tracking adverse events. Some sites may also perform special imaging tests to explore tissue oxygenation and wound characteristics. The main outcomes measured are the rate of complete wound closure at 12 weeks and the percentage reduction in ulcer size. Secondary outcomes include pain changes and adverse events, with follow-up visits continuing as scheduled for up to 12 weeks.
CONDITIONS
Brief Title
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- History of Type I or Type II Diabetes Mellitus treated with oral medications and/or insulin
- Diabetic foot ulcer present for more than 4 weeks but less than 12 months
- Less than 25% wound area reduction during a two-week screening period
- Ulcer size between 1.0 cm² and 25 cm² after debridement
- Ulcer grade Wagner 1 or 2 located on any foot area with at least 50% below the malleolus
- Adequate circulation to the affected foot as shown by specific oxygen or pressure measurements
- Negative pregnancy test for females of childbearing potential and use of contraception during study
- Ulcer offloaded with study-defined device for at least 14 days before randomization
- Ulcer has a clean base free of dead tissue at treatment start
- Ability and willingness to follow study protocol
- Signed informed consent
You will not qualify if you...
- Life expectancy less than 1 year
- Ulcer present for more than 1 year
- Inadequate two-week historical data showing less than 25% wound reduction
- Unable to comply with offloading device
- Conditions compromising ability to complete study or poor adherence history
- Ulcers with completely dead or fibrotic tissue
- Major uncontrolled medical disorders (serious heart, kidney, liver, lung diseases, lupus, palliative care, sickle cell anemia)
- Active or recent malignant disease in ulcer area
- Other conditions risking safety or study completion
- Allergies or contraindications to acellular dermal matrices or Miro3D components
- Participation in another interfering clinical trial
- Ulcers showing more than 25% reduction after two weeks of standard care
- Pregnancy or breastfeeding
- Recent or anticipated immunosuppressant use or chemotherapy
- Ulcers previously treated with tissue-engineered or scaffold materials within 30 days
- Need for hyperbaric oxygen therapy during the trial or shortly before
- Poor diabetes metabolic control (HbA1c ≥ 12.0)
- Presence of gangrene or unstable ischemia in ulcer or limb
- Recent revascularization surgery on affected limb
- Ulcers suspected of cancer requiring biopsy
- Any other significant health risks identified by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive either Miro3D Wound Matrix plus standard of care or standard of care alone. Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Weekly visits for up to 12 weeks
Duration - 2 weeks after wound closure
Participants who achieve complete wound closure return for a healing confirmation visit two weeks after closure is initially documented.
1 visit (in-person) for healing confirmation
Trial Site Locations
Total: 14 locations
1
Advanced Foot Care
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
West Boca Center for Wound Healing
Coconut Creek, Florida, United States, 33073
Not Yet Recruiting
3
Solutions Medical Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
4
Doctors Research Network
Miami, Florida, United States, 33156
Not Yet Recruiting
5
Barry University
Tamarac, Florida, United States, 33321
Actively Recruiting
6
Clinical Trials of New England
Hyde Park, Massachusetts, United States, 02136
Not Yet Recruiting
7
Mercy Hyperbaric and Wound Care
St Louis, Missouri, United States, 63128
Not Yet Recruiting
8
St. Louis Foot & Ankle
St Louis, Missouri, United States, 63128
Not Yet Recruiting
9
Christian Hospital Wound Center
St Louis, Missouri, United States, 63136
Not Yet Recruiting
10
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
11
ABC Podiatry
Columbus, Ohio, United States, 43213
Actively Recruiting
12
Dynamic Wound Care
Oklahoma City, Oklahoma, United States, 73159
Not Yet Recruiting
13
Caring Foot and Ankle Specialists
Houston, Texas, United States, 77035
Actively Recruiting
14
Vital Heart and Vein
Humble, Texas, United States, 77338
Actively Recruiting
Research Team
E
Erin Badali
G
Greg Smock
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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