OASIS Wound Matrix (Oasis) Mechanism of Action
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00570141|
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : August 9, 2010
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers (DFU) Venous Stasis Ulcers (VSU)||Device: OASIS Wound Matrix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS|
|Study Start Date :||October 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2010|
Active Comparator: OASIS Wound Matrix (Oasis)
This is a single arm study with only the test article Oasis used on all subjects
Device: OASIS Wound Matrix
OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
- Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. [ Time Frame: Baseline and weekly up to 12 weeks ]
Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.
Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)
- Percent Wounds Closed [ Time Frame: baseline and 12 weeks ]
Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.
The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570141
|United States, Arkansas|
|Sparks Regional Medical Center|
|Fort Smith, Arkansas, United States, 72901|
|United States, Missouri|
|Bay Pines VA Healthcare System|
|St. Louis, Missouri, United States|
|United States, Utah|
|Dixie Regional Medical Center Wound Clinic|
|St. George, Utah, United States, 84770|
|Principal Investigator:||W. Payne, M.D.||Bay Pines VA Healthcare System|
|Principal Investigator:||Carl Van Gils, DPM, CWS||Dixie Regional Medical Center Wound Clinic|
|Principal Investigator:||Davin Haraway, DO||Sparks Regional Medical Center|