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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108263
• Other study ID #: 2010-006
• Status: Terminated
• Phase: Phase 4
• First received: April 20, 2010
• Last updated: February 3, 2014
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington, D.C	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Decrease in Wound Size		12 weeks	No
Secondary	Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.		12 weeks	No