OASIS Wound Matrix (Oasis) Mechanism of Action

Healthpoint13 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

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

Interventions

OASIS Wound MatrixDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Bay Pines VA Healthcare System

St Louis, Missouri, United States

Dixie Regional Medical Center Wound Clinic

St. George, Utah, United States

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: baseline and 12 weeks

Data from ClinicalTrials.gov

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