Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

Participant does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity.
Participant has a known life expectancy of \<1 year.
Participant is unable to comply with protocol treatment.
Participant has comorbid conditions, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders. that may compromise participant's safety or wound healing in the opinion of the Investigator.
Participant actively (or having a history) being treated for malignant disease, or history of malignancy or radiation therapy at the site of wound.
HbA1c \>12% (HbA1c must be ≤12% at screening, measured within 30 days prior to Randomization (Christman et al. 2011, Snyder et al. 2010), or renal failure defined as eGFR \<30 mL/min/1.73m² (CKD stage 4-5) at Screening, or end-stage renal disease requiring dialysis).
Known contraindications to bioabsorbable advanced wound matrix
Concurrent participation in alternative clinical trial that involves investigational drug or cellular, acellular, and matrix-like products that may interfere with wound treatment and/or healing
Participant is pregnant or breastfeeding.
History of immunosuppressant treatment (systemic corticosteroids \>10mg/ day), cytotoxic chemotherapy, or topical steroid application to the wound for \>2 weeks within 30 days prior to Randomization, or anticipated use of any of the above during the course of the study
Wound previously treated with cellular, acellular, or matrix-like products, tissue engineered constructs, or scaffold materials within 30 days prior to Randomization
Wound depth with visible exposed bone or hardware
Hyperbaric oxygen therapy (HBO) or Negative Pressure Wound Therapy (NPWT) within 28 days prior to Randomization
Planned or recent (within 30 days prior to Screening) revascularization surgery/procedure or venous intervention of the target wound limb, including arterial revascularization (endovascular or open bypass), or anticipated need for revascularization during the treatment period, as determined by vascular assessment
For arterial procedure: including but not limited to endovascular or open bypass
+6 more criteria

Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Borate-based Bioactive Glass Fiber Matrix (BBGFM) plus Standard of Care

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Borate-based Bioactive Glass Fiber Matrix (BBGFM) plus Standard of Care

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record