Loading clinical trials...
Loading clinical trials...
The Use of INTEGRA™ Flowable Wound Matrix to Manage Diabetic Foot Ulcers in High Risk Populations: A Prospective, Randomized, Controlled Trial
* 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Start Date
June 1, 2010
Primary Completion Date
August 1, 2011
Completion Date
August 1, 2011
Last Updated
March 17, 2014
5
ACTUAL participants
INTEGRA™ Flowable Matrix (Collagen)
DRUG
Lead Sponsor
Georgetown University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07296484