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OASIS Wound Matrix (Oasis) Mechanism of Action

This study has been completed.
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00570141
First received: December 6, 2007
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Foot Ulcers (DFU)
Venous Stasis Ulcers (VSU)
 Device: OASIS Wound Matrix
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • 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).



Enrollment: 13
Study Start Date: October 2007
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570141

Locations
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
Sponsors and Collaborators
Healthpoint
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
  More Information

No publications provided

Responsible Party: Innes Cargill, PhD, Director, Clinical Affairs Tissue Management, Healthpoint, Ltd.
ClinicalTrials.gov Identifier: NCT00570141     History of Changes
Other Study ID Numbers: 9310-002-004
Study First Received: December 6, 2007
Results First Received: June 9, 2010
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Foot Ulcer
Diabetic Foot
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
 Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Foot Diseases
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 23, 2013