Title
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
Phase
Phase 4Lead Sponsor
Georgetown UniversityStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Diabetes Foot UlcerIntervention/Treatment
collagen ...Study Participants
5After 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.
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.
INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
Inclusion Criteria: Subject is 18 years of age or older Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation. Subject has Diabetes Mellitus (type 1 or type 2). University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm². Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. Exclusion Criteria: Subjects < 18 years of age Subject is non-diabetic Subjects who present with wounds of etiology other than diabetes Subject demonstrates increased signs of clinical infection Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. University of Texas Classification greater than grade 1A Diabetic plantar foot wounds measuring >4.0cm² Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing Subjects participating in any other trials in regards to the diabetic foot ulcer
| Event Type | Organ System | Event Term | Integra Flowable on Wound Bed | INTEGRA Flowable on Wound & Injected Subcutaneously |
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