Using Miro3D Wound Matrix to Heal Complex Wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effectiveness of Miro3D Wound Matrix, a biologically derived acellular scaffold made from porcine liver tissue, in healing complex wounds and ulcerations in an outpatient setting. The trial is designed as a post-market, proof-of-concept evaluation, where the Miro3D matrix is applied alongside standard wound care practices. Up to 20 adult participants with chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence will be enrolled to assess the matrix's impact on wound closure and pain reduction over a 12-week treatment phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 or older and able to provide informed consent.
2. Has an open wound or ulceration, preferably with tunneling or undermining.
3. If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
4. Other wounds must be ≥2 cm away from the study wound.
5. Wound should be debrided with a clinical goal of healing, even if some infection remains.
6. Previous infections must be adequately treated and controlled (per IDSA guidelines).
7. Willing and able to comply with offloading and/or compression requirements.
8. Must have a stable living environment for wound care adherence.
9. Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
10. Provides consent for digital photo documentation.

Exclusion Criteria:

1. Active, untreated osteomyelitis.
2. Malignancy or vasculitis at the wound site.
3. Undergoing chemotherapy.
4. On dialysis.
5. Use of investigational drugs or therapies within 30 days before screening.
6. Conditions that significantly impair study adherence or known history of medical non-compliance.
7. Known sensitivity to porcine materials.
8. Third-degree burns.
9. Worsening ischemia or gangrene at screening.
10. Prior radiation to the study wound site.
11. Exposed hardware, implants, or fixation devices in the study wound.
12. Receiving palliative or comfort care.

Where it's running

• Barry University Clinical Research
  Tamarac, Florida, United States Recruiting
• West Boca Center for Wound Healing
  Coconut Creek, Florida, United States Not yet recruiting

Study contacts

• Principal investigator: Robert J. Snyder, DPM — Barry University
• Study coordinator: Maria Swartz
• Email: mswartz@barry.edu
• Phone: 954-721-4806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Miro3D Wound Matrix for Diabetic Foot Ulcers

  This study tests whether adding Miro3D Wound Matrix to standard care helps healing diabetic foot ulcers in adults.

  Recruiting at 6 sites Reprise Biomedical, Inc. · Phoenix, Arizona and 13 other locations · NCT07632001

• Registry of Chronic Wounds and Ulcers

  This study collects information from patients with chronic wounds and ulcers to see how well different treatments are working and to improve the quality of wound care.

  Recruiting U.S. Wound Registry · The Woodlands, Texas · NCT02280733

• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

  This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.

  Recruiting Biointelligent Technology Systems SL · Barcelona · NCT07617961

• Nu-3 Gel at multiple doses for mildly infected diabetic foot ulcers

  A phase 2a study will test whether Nu-3 gel, applied on infected diabetic foot ulcers, can reduce bacteria and help heal at three different dose levels in adults with diabetes.

  Recruiting at 6 sites Phase 2 Lakewood-Amedex Inc · Los Angeles, California and 5 other locations · NCT07565506

• Nitric oxide–generating dressing for diabetic foot ulcers

  This real-world study tests a nitric oxide–generating dressing on adults with diabetic foot ulcers to see how well it works and how safe it is.

  Recruiting ConvaTec Inc. · Ashton-under-Lyne, England · NCT07438951

• See if Hyalomatrix helps heal venous leg ulcers faster when added to standard care

  This trial tests whether adding Hyalomatrix to standard wound care helps people with venous leg ulcers heal more effectively.

  Recruiting at 9 sites NuScience Medical Biologics, LLC · Alexandria, Louisiana and 11 other locations · NCT07335861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.