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

NCT01108263 | Terminated Phase 4 Results

• 1 other identifier: 2010-006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Decrease in Wound Size

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

Integra Flowable on wound bed

ACTIVE COMPARATOR

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 on wound & injected subcutaneously

ACTIVE COMPARATOR

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)

Interventions

INTEGRA™ Flowable Matrix (Collagen) 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.

Also known as: Integra Flowable Wound Matrix

INTEGRA Flowable on wound & injected subcutaneously; Integra Flowable on wound bed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Interventions

Collagen

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. John Steinberg, Principal Investigator
• Organization: Georgetown University

zr40@georgetown.edu

202-444-0793

Study Officials

• John Steinberg, DPM

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 17, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-02

Locations

US (1)