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Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers

2014-08-27 03:14:26 | BioPortfolio

Summary

- After determining if subjects meet the criteria to be included in the study, the wound will be debrided (cleansed of any dead tissue or infection).

- 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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes

Intervention

INTEGRA™ Flowable Matrix (Collagen)

Location

Georgetown University Hospital
Washington, D.C
District of Columbia
United States
20007

Status

Recruiting

Source

Georgetown University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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Medical and Biotech [MESH] Definitions

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.

Collagen receptors are cell surface receptors that modulate signal transduction between cells and the EXTRACELLULAR MATRIX. They are found in many cell types and are involved in the maintenance and regulation of cell shape and behavior, including PLATELET ACTIVATION and aggregation, through many different signaling pathways and differences in their affinities for collagen isoforms. Collagen receptors include discoidin domain receptors, INTEGRINS, and glycoprotein VI.

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