OASIS Wound Matrix (Oasis) Mechanism of Action

June 7, 2011 updated by: Healthpoint

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • Missouri
      • St. Louis, Missouri, United States
        • Bay Pines VA Healthcare System
    • Utah
      • St. George, Utah, United States, 84770
        • Dixie Regional Medical Center Wound Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

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
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).
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (ESTIMATE)

December 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

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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