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New treatment option for Diabetic Foot Ulcers (DFUs)
Official title Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
ClinicalTrials.gov ID: NCT06939686
What this study is testing
- What it's testing
- This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and wound dehiscence in an outpatient setting. The trial is sponsored by Reprise Biomedical, Inc.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be at least 18 years of age and capable of providing informed consent.
- Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be...
- Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
- Wound/ulcer must have been present for at least 4 weeks prior to screening.
- Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic/biphasic Doppler...
You likely can't join if
- Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline.
- Poorly controlled diabetes (HbA1c ≥ 12%).
- Active, untreated or uncontrolled osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
See the full eligibility criteria
- Must be at least 18 years of age and capable of providing informed consent.
- Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus.
- Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
- Wound/ulcer must have been present for at least 4 weeks prior to screening.
- Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic/biphasic Doppler waveforms.
- Other wounds, if present, must be at least 2 cm from the index wound/ulcer.
- Any previous infections must have been adequately treated per IDSA guidelines.
- people must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits.
- Must provide written consent for digital imaging.
- For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement.
- Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline.
- Poorly controlled diabetes (HbA1c ≥ 12%).
- Active, untreated or uncontrolled osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days prior to screening.
- Conditions that would compromise study participation or adherence.
- Known sensitivity to porcine materials.
- Third-degree burns.
- Worsening ischemia or gangrene at screening.
- History of radiation to the wound site.
- Exposed internal fixation, implants, or hardware in the wound.
- Patient is transitioning to palliative or comfort care.
The study team makes the final eligibility decision.
Where it's taking place
- Coconut Creek, Florida, United States
- Tamarac, Florida, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coconut Creek, Florida, United States; Tamarac, Florida, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.