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

NCT ID: NCT01108263

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integra Flowable on 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.

Group Type: ACTIVE_COMPARATOR

INTEGRA™ Flowable Matrix (Collagen)

Intervention Type: DRUG

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 on wound & injected subcutaneously

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.

Group Type: ACTIVE_COMPARATOR

INTEGRA™ Flowable Matrix (Collagen)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Integra Flowable Wound Matrix

Eligibility Criteria

Inclusion Criteria

1. Subject is 18 years of age or older

2. Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation.

3. Subject has Diabetes Mellitus (type 1 or type 2).

4. University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm².

5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.

Exclusion Criteria

1. Subjects < 18 years of age

2. Subject is non-diabetic

3. Subjects who present with wounds of etiology other than diabetes

4. Subject demonstrates increased signs of clinical infection

5. 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.

6. University of Texas Classification greater than grade 1A

7. Diabetic plantar foot wounds measuring >4.0cm²

8. Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing

9. Subjects participating in any other trials in regards to the diabetic foot ulcer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

John Steinberg, DPM

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Steinberg, DPM

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Locations

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2010-006

Identifier Type: -

Identifier Source: org_study_id