OASIS Wound Matrix (Oasis) Mechanism of Action

Diabetic Foot Ulcers (DFU) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570141
• Other study ID #: 9310-002-004
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2007
• Last updated: June 7, 2011
• Start date: October 2007
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers (DFU)
• Foot Ulcer
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers (VSU)

Intervention

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

Locations

Country	Name	City	State
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Dixie Regional Medical Center Wound Clinic	St. George	Utah
United States	Bay Pines VA Healthcare System	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No