NCT01108263

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

The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. * 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. * Both groups will be debrided and have pictures taken in the OR * Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR. * 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.

Conditions

• Diabetes
• Foot Ulcer

Interventions

Type	Name	Description
DRUG	INTEGRA™ Flowable Matrix (Collagen)	INTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-04-21
• Last updated: 2014-03-17
• Results posted: 2014-03-17

Locations

1 site across 1 country: United States