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New treatment option for Diabetic Foot Ulcers (DFUs)
Official title Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT07632001
What this study is testing
- What it's testing
- 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.
- 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
- people 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...
- Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.
- Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
You likely can't join if
- 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.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to...
- Subject has ulcers that are completely necrotic or fibrotic tissue.
See the full eligibility criteria
Who can join
- people 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.
- Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
- Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent. people with the following ulcer: A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below...
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; Toe pressures \>50mmHg; an ABI between 0.7 and...
- Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of...
- The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1/Randomization).
- The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.
What rules you out
- 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.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
- Subject has ulcers that are completely necrotic or fibrotic tissue.
- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or people with history of malignancy within the ulcer.
- The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
- Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Index ulcer has reduced in area by ≥25% after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- Subject is pregnant or breastfeeding.
- people with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface...
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) including any other CAMP within the last 30 days preceding the...
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.
- Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
- Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
- Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
- Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
- Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Coconut Creek, Florida, United States
- Coral Gables, Florida, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- Hyde Park, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Humble, Texas, 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 Phoenix, Arizona, United States; Coconut Creek, Florida, United States; Coral Gables, Florida, United States; Miami, Florida, United States; Tamarac, Florida, United States; Hyde Park, Massachusetts, United States and 6 more location(s). 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.