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- Subjects will then be randomly placed in either Group 1 or 2.
- The INTEGRA™ Flowable Matrix will be placed on the wound, at the first visit in both groups.
- In Group 2, INTEGRA™ Flowable Matrix will also be injected deep to the wound.
- Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit.
- Subjects will be placed in a total contact cast at each visit.
If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
INTEGRA™ Flowable Matrix (Collagen)
Georgetown University Hospital
District of Columbia
Published on BioPortfolio: 2014-08-27T03:14:26-0400
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An endopeptidase that is structurally similar to MATRIX METALLOPROTEINASE 2. It degrades GELATIN types I and V; COLLAGEN TYPE IV; and COLLAGEN TYPE V.
A non-fibrillar collagen that forms a network of MICROFIBRILS within the EXTRACELLULAR MATRIX of CONNECTIVE TISSUE. The alpha subunits of collagen type VI assemble into antiparallel, overlapping dimers which then align to form tetramers.
A small leucine-rich proteoglycan that contains 4 KERATAN SULFATE chains within the leucine repeat region. It interacts with COLLAGEN TYPE I and COLLAGEN TYPE II fibrils and may function to control the rate of EXTRACELLULAR MATRIX assembly. It also sequesters TRANSFORMING GROWTH FACTOR BETA in the extracellular matrix.
A member of the MATRIX METALLOPROTEINASES that cleaves triple-helical COLLAGEN types I, II, and III.
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