Expired Study
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Fort Smith, Arkansas 72901


Purpose:

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.


Study summary:

Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).


Criteria:

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 is Available At:


Original ID:

9310-002-004


NCT ID:

NCT00570141


Secondary ID:


Study Acronym:


Brief Title:

OASIS Wound Matrix (Oasis) Mechanism of Action


Official Title:

Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Healthpoint


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:W. Payne, M.D.
Principal Investigator
Bay Pines VA Healthcare System

Study Dates

Start Date:October 2007
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 7, 2011
First Received Date:December 6, 2007
First Results Date:June 9, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percent Wounds Closed
Time Frame:baseline and 12 weeks
Safety Issues:False
Description: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 wou
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 c

Study Interventions

Intervention Type:Device
Name:OASIS Wound Matrix
Description:OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).
Arm Name:OASIS Wound Matrix (Oasis)

Study Arms

Study Arm Type:Active Comparator
Arm Name:OASIS Wound Matrix (Oasis)
Description:This is a single arm study with only the test article Oasis used on all subjects

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Healthpoint

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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