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Feasibility Study of a Novel Device for Chronic Wounds

This study is currently recruiting participants

Study NCT00660049.   Last updated on January 14, 2009.

Information provided by Stanford University

Brief Summary

The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

Study Type Interventional
Study Design Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure Ease of use for patients and clinicians
Secondary Outcome Measure Suggestions for improvement
Condition Ulcer, n Ulcer, Wounds and Injuries
Intervention Device: SNaP Advanced Wound Care System
Recruitment Information
Recruitment Status Recruiting
Enrollment 30
Start Date March 2008
Eligibility Criteria

Inclusion Criteria: Venous stasis ulcer or other chronic wound on the lower extremity that is <6 cm in widest diameter.

  • The wound must have at least 2 cm of intact epithelium surrounding it.
  • A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.
  • Ulcer must not have healed for >14 days.
  • Chronic wound with prior graft placement will be allowed in the study.
  • Patient is >18 years old and <90 years old.
  • Willing and able to sign informed consent.&#xA; Exclusion Criteria:- Active wound infection.
  • 2+ or greater pitting edema of lower extremity
  • History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.
  • Thick eschar at wound base after debridement.
  • Wound location is not amenable to forming an airtight seal and placement of device.
  • Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, calcinosis cutis, scleroderma, Raynaud's syndrome.
  • Current smoker (must have quit for >3 weeks)
  • Wound with exposed bone, blood vessels, tendon
  • Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone
  • Fasting blood sugar >200
  • Ankle brachial index less than lower limit of normal (<0.60)
  • Pregnancy
  • Incapable of giving informed consent
  • Inability to comply with study procedures including lack of telephone access
Gender Both
Ages 18 Years to 90 Years
Contact

Emily S Gorell, BA
Tel: 650.725.4302
egorell@stanford.edu

Location Countries United States
Administrative Information
NCT ID NCT00660049
Organization ID SU-02252008-1026
Secondary IDs IRB Protocol #: 11074
Study Sponsor Stanford University
Collaborators Spiracur, Inc.
Investigators
Principal Investigator:
Dr. Anne Lynn S. Chang
Stanford University
Information Provided By Stanford University
Verification Date January 2009
First Received Date April 4, 2008
Last Updated Date January 14, 2009

Source

Added February 17, 2009

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