OASIS Wound Matrix (Oasis) Mechanism of Action
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
Diabetic Foot Ulcers (DFU)
Venous Stasis Ulcers (VSU)
Device: OASIS Wound Matrix
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS|
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).
|Study Start Date:||October 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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).
Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
Please refer to this study by its ClinicalTrials.gov identifier: 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|