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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Foot Ulcer

Intervention / Treatment
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* Drug: INTEGRA™ Flowable Matrix (Collagen)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integra Flowable on wound bed<br>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. | Drug: INTEGRA™ Flowable Matrix (Collagen)<br>* 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.<br>* Other names: Integra Flowable Wound Matrix;|
| Active Comparator: INTEGRA Flowable on wound & injected subcutaneously<br>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. | Drug: INTEGRA™ Flowable Matrix (Collagen)<br>* 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.<br>* Other names: Integra Flowable Wound Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Decrease in Wound Size |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values. |  | 12 weeks |