OASIS Wound Matrix (Oasis) Mechanism of Action

NCT00570141 | Completed Phase 4 Results

• 1 other identifier: 9310-002-004
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.

  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

  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

Study Arms (1)

OASIS Wound Matrix (Oasis)

ACTIVE COMPARATOR

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

Device: OASIS Wound Matrix

Interventions

OASIS Wound Matrix DEVICE

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

OASIS Wound Matrix (Oasis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health

You may not qualify if:

• Contraindications or hypersensitivity to the use of the study medications or their components

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (3)

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

Bay Pines VA Healthcare System

St Louis, Missouri, United States

Location

Dixie Regional Medical Center Wound Clinic

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Results Point of Contact

• Title: Herbert B. Slade, M.D., FAAAI
• Organization: Healthpoint, Ltd.

bert.slade@healthpoint.com

917-900-4000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 9, 2011
• Results First Posted: August 9, 2010

Record last verified: 2011-06

Locations

US (3)