Clinical trial NCT01108263: Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers
Official title: The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Foot Ulcer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2010-04-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Decrease in Wound Size
timeFrame: 12 weeks
Secondary outcomes:
measure: Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington, D.C
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: John Steinberg, DPM
role: PRINCIPAL_INVESTIGATOR
References: