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Completed

NCT Number: NCT00570141

OASIS Wound Matrix (Oasis) Mechanism of Action

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

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Key information

Conditions

Diabetic Foot Ulcers (DFU) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Stasis Ulcers (VSU)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sparks Regional Medical Center, Fort Smith, Arkansas, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OASIS Wound Matrix

Device

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

Primary outcomes

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

    Time frame: 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)

  2. Percent Wounds Closed

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Dec 10, 2007
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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