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

Primary Purpose

Diabetes, Foot Ulcer

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
INTEGRA™ Flowable Matrix (Collagen)
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Integra Flowable on wound bed

INTEGRA Flowable on wound & injected subcutaneously

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Decrease in Wound Size

Secondary Outcome Measures

Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.

Full Information

First Posted
April 20, 2010
Last Updated
February 3, 2014
Sponsor
Georgetown University
Collaborators
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01108263
Brief Title
Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
Official Title
The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integra Flowable on wound bed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
INTEGRA Flowable on wound & injected subcutaneously
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INTEGRA™ Flowable Matrix (Collagen)
Other Intervention Name(s)
Integra Flowable Wound Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Decrease in Wound Size
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Steinberg, DPM
Organizational Affiliation
Georgetown University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington, D.C
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

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

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