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: February 3, 2014
Last verified: February 2014
  Purpose
  • 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.


Condition Intervention Phase
Diabetes
Foot Ulcer
Drug: INTEGRA™ Flowable Matrix (Collagen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Overall Decrease in Wound Size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: June 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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
Active Comparator: 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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108263

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, D.C, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Integra LifeSciences Corporation
Investigators
Principal Investigator: John Steinberg, DPM Georgetown University Hospital
  More Information

No publications provided

Responsible Party: John Steinberg, DPM, Principle Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT01108263     History of Changes
Other Study ID Numbers: 2010-006
Study First Received: April 20, 2010
Results First Received: July 1, 2013
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Foot Diseases

ClinicalTrials.gov processed this record on September 22, 2014