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

Phase 4

Terminated

• Conditions: Foot Ulcer; Diabetes
• Interventions: Drug: INTEGRA™ Flowable Matrix (Collagen)

• Registration Number: NCT01108263
• Lead Sponsor: Georgetown University

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 available

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-21
• Study Start: 2010-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2013-07-01
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-03
• Last Update Submitted: 2014-02-03
• Results First Posted: 2014-03-17
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integra Flowable on wound bed	INTEGRA™ Flowable Matrix (Collagen)	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 on wound & injected subcutaneously	INTEGRA™ Flowable Matrix (Collagen)	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.

Primary Outcome Measures

Name	Time	Method
Overall Decrease in Wound Size	12 weeks

Secondary Outcome Measures

Name	Time	Method
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.	12 weeks

Trial Locations

Locations (1)

Georgetown University Hospital; 🇺🇸 Washington, D.C, District of Columbia, United States