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Official title Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
ClinicalTrials.gov ID: NCT06939673
What this study is testing
- What it's testing
- This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue.
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
- Age 18 or older and able to provide informed consent.
- Has an open wound or ulceration, preferably with tunneling or undermining.
- If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
- Other wounds must be ≥2 cm away from the study wound.
- Wound should be debrided with a clinical goal of healing, even if some infection remains.
You likely can't join if
- Active, untreated osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days before screening.
- Conditions that significantly impair study adherence or known history of medical non-compliance.
See the full eligibility criteria
- Age 18 or older and able to provide informed consent.
- Has an open wound or ulceration, preferably with tunneling or undermining.
- If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
- Other wounds must be ≥2 cm away from the study wound.
- Wound should be debrided with a clinical goal of healing, even if some infection remains.
- Previous infections must be adequately treated and controlled (per IDSA guidelines).
- Willing and able to comply with offloading and/or compression requirements.
- Must have a stable living environment for wound care adherence.
- Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
- Provides consent for digital photo documentation.
- Active, untreated osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days before screening.
- Conditions that significantly impair study adherence or known history of medical non-compliance.
- Known sensitivity to porcine materials.
- Third-degree burns.
- Worsening ischemia or gangrene at screening.
- Prior radiation to the study wound site.
- Exposed hardware, implants, or fixation devices in the study wound.
- Receiving 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
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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. Enter your location above to see the nearest site and check your eligibility.
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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.