- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570141
OASIS Wound Matrix (Oasis) Mechanism of Action
Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arkansas
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Fort Smith, Arkansas, United States, 72901
- Sparks Regional Medical Center
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Missouri
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St. Louis, Missouri, United States
- Bay Pines VA Healthcare System
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Utah
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St. George, Utah, United States, 84770
- Dixie Regional Medical Center Wound Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health
Exclusion Criteria:
- Contraindications or hypersensitivity to the use of the study medications or their components
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: OASIS Wound Matrix (Oasis)
This is a single arm study with only the test article Oasis used on all subjects
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OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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) |
Baseline and weekly up to 12 weeks
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Percent Wounds Closed
Time Frame: baseline and 12 weeks
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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). |
baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9310-002-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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