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Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers

NCT07632001 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-13

No results posted yet for this study

Summary

This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.

Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone.

Miro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone.

Approximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits.

The primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.

Conditions

  • Diabetic Foot Ulcers (DFUs)
  • Diabetic Foot
  • Chronic Wounds

Interventions

DEVICE

Miro3D Wound Matrix

Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue and applied topically to the wound following appropriate wound bed preparation to support tissue regeneration and healing.

OTHER

Standard of Care

Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Sponsors & Collaborators

  • Reprise Biomedical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-03-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632001 on ClinicalTrials.gov