OASIS Wound Matrix (Oasis) Mechanism of Action

NCT ID: NCT00570141

Last Updated: 2011-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Diabetic Foot Ulcers (DFU) Venous Stasis Ulcers (VSU)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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OASIS Wound Matrix (Oasis)

This is a single arm study with only the test article Oasis used on all subjects

Group Type ACTIVE_COMPARATOR

OASIS Wound Matrix

Intervention Type DEVICE

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

Interventions

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OASIS Wound Matrix

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healthpoint

INDUSTRY

Sponsor Role lead

Responsible Party

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Healthpoint, Ltd.

Principal Investigators

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W. Payne, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bay Pines VA Healthcare System

Carl Van Gils, DPM, CWS

Role: PRINCIPAL_INVESTIGATOR

Dixie Regional Medical Center Wound Clinic

Davin Haraway, DO

Role: PRINCIPAL_INVESTIGATOR

Sparks Regional Medical Center

Locations

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Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Site Status

Bay Pines VA Healthcare System

St Louis, Missouri, United States

Site Status

Dixie Regional Medical Center Wound Clinic

St. George, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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9310-002-004

Identifier Type: -

Identifier Source: org_study_id

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