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

This study has been terminated.

(Sponsor Terminated)

Sponsor:

Collaborator:

Integra LifeSciences Corporation

Information provided by (Responsible Party):

John Steinberg, DPM, Georgetown University

ClinicalTrials.gov Identifier:

NCT01108263

First received: April 20, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

June 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall decrease in wound size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01108263 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decreased peak plantar pressures in both the static and dynamic phases of gait as compared to pre-operative pressure values. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Foot Ulcer

Intervention ^ICMJE

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.

Other Name: Integra Flowable Wound Matrix

Study Arm (s)

Active Comparator: Integra Flowable on wound bed
Intervention: Drug: INTEGRA™ Flowable Matrix (Collagen)
Active Comparator: INTEGRA Flowable on wound & injected subcutaneously
Intervention: Drug: INTEGRA™ Flowable Matrix (Collagen)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01108263

Other Study ID Numbers ^ICMJE

2010-006

Has Data Monitoring Committee

Responsible Party

John Steinberg, DPM, Georgetown University

Study Sponsor ^ICMJE

Georgetown University

Collaborators ^ICMJE

Integra LifeSciences Corporation

Investigators ^ICMJE

Principal Investigator:

John Steinberg, DPM

Georgetown University Hospital

Information Provided By

Georgetown University

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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