Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReprise Biomedical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 18 years of age or older.
Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.
Disqualifiers
Subject has a known life expectancy of < 1 year.
Index ulcer has been present for >1 year.
Patient does not have adequate 2-week historical data demonstrating < 25% area reduction.
Subject is unable to comply with offloading device.
Trial design
Design model
Parallel
Treatments tested in this trial
Miro3D Wound Matrix
DeviceMiro3D 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.
Standard of Care
Other interventionStandard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Miro3D Wound Matrix Plus Standard of CareExperimental treatment 2 interventions
Group B: Standard of Care AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
Complete wound closure is defined as full re-epithelialization of the target ulcer without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted approximately two weeks after complete closure is initially documented.
Time frame
Up to 12 weeks2
Mean Percentage Reduction in Target Ulcer Surface Area From Baseline to 12 Weeks
Percentage area reduction (PAR) is defined as the percent change in surface area of the target ulcer from baseline, as measured by digital planimetry.
Time frame
Baseline through 12 weeksSecondary outcomes
1
Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
Ulcer-associated pain will be assessed using the Numeric Pain Rating Scale (NPRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain).
Time frame
Baseline through 12 weeks2
Number of Participants Experiencing Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be collected and coded throughout the study period and summarized by treatment group.
Time frame
Up to 12 weeksOther outcomes
1
Change From Baseline in Tissue Oxygenation (StO₂) Values at Technology-Enabled Sites
Exploratory assessment of change from baseline in tissue oxygenation (StO₂) values measured using imaging technology at technology-enabled study sites. Outcome data will include longitudinal changes in measured StO₂ values collected during the study period.
Time frame
Baseline through 12 weeks2
Change From Baseline in Fluorescence Imaging Signal Values at Technology-Enabled Sites
Exploratory assessment of change from baseline in fluorescence imaging signal values measured using imaging technology at technology-enabled study sites. Outcome data will include longitudinal changes in measured fluorescence imaging signal values collected during the study period.
Time frame
Baseline through Week 12Sponsors and contacts
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Source ClinicalTrials.gov