OASIS Wound Matrix (Oasis) Mechanism of Action

Phase 4

Completed

• Conditions: Venous Stasis Ulcers (VSU); Diabetic Foot Ulcers (DFU)
• Interventions: Device: OASIS Wound Matrix

• Registration Number: NCT00570141
• Lead Sponsor: Healthpoint

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2009-04
• Study Completion: 2010-04
• Results First Submitted: 2010-06-09
• Results First Submitted QC: 2010-07-14
• Results First Posted: 2010-08-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OASIS Wound Matrix (Oasis)	OASIS Wound Matrix	This is a single arm study with only the test article Oasis used on all subjects

Primary Outcome Measures

Name	Time	Method
Percent Wounds Closed	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).
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.	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)

Trial Locations

Locations (3)

Bay Pines VA Healthcare System; 🇺🇸 St. Louis, Missouri, United States

Sparks Regional Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Dixie Regional Medical Center Wound Clinic; 🇺🇸 St. George, Utah, United States