OASIS Mechanism of Action - Full Text View

Sponsored by:	Healthpoint
Information provided by:	Healthpoint
ClinicalTrials.gov Identifier:	NCT00570141

Purpose

OASIS will be applied to wounds, with sequential biopsy of healing wounds to explore mechanism.

Condition	Intervention	Phase
Diabetic Foot Ulcers Venous Stasis Ulcers	Device: Oasis Wound Matrix	Phase IV

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Single Group Assignment
Official Title:	Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS

Further study details as provided by Healthpoint:

Primary Outcome Measures:

Histology [ Time Frame: Multiple ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetic foot ulcer or venous stasis ulcer of the leg, with certain restrictions on size, duration and underlying health

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

Responsible Party:	Healthpoint, Ltd. ( Innes Cargill, PhD, Director, Clinical Affairs Tissue Management )
Study ID Numbers:	9310-002-004
Study First Received:	December 6, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00570141
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Postthrombotic Syndrome
Foot Diseases
Diabetic Angiopathies
Varicose Veins
Venous Insufficiency
Phlebitis
Venous Thrombosis
Postphlebitic Syndrome
Diabetes Complications
Foot Ulcer
Peripheral Vascular Diseases
Skin Diseases
Diabetic Neuropathies

Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Thrombosis
Varicose Ulcer
Embolism and Thrombosis
Embolism
Endocrinopathy
Skin Ulcer
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009