Feasibility Study of a Novel Device for Chronic Wounds

This study has been completed.
Sponsor:
Collaborator:
Spiracur, Inc.
Information provided by (Responsible Party):
Anne Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT00660049
First received: April 4, 2008
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Ulcer
Wounds and Injuries
Device: SNaP Advanced Wound Care System
Other: SNaP

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of a Novel Device for Chronic Wounds

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Ease of use for patients and clinicians [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    In vivo use of SNaP device


Secondary Outcome Measures:
  • Suggestions for improvement [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    We will ask patients for feedback on usage


Enrollment: 12
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNaP application
This is an "open label" pilot study of SNaP Advanced Wound Care System
Device: SNaP Advanced Wound Care System
Application of negative pressure device daily per instructions
Other Name: SNaP device (SmartNegative Pressure device)
Other: SNaP
Daily use
Other Name: SNaP device
Other: SNaP
Daily application per protocol
Other Name: SNaP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point

  • 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 under standard treatment.
  • Chronic wound with prior graft placement will be allowed in the study.
  • Patient is >18 years old.
  • Willing and able to sign informed consent.

Exclusion Criteria:- Active wound infection.

  • 3+ 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, necrobiosis lipoidica diabeticorum, lupus or pancreatic pannuculitis, cryofibrinogenemia, 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 by study personnel administered bedside fingerstick blood glucose
  • Ankle brachial index less than lower limit of normal (<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).
  • Pregnancy
  • Incapable of giving informed consent
  • Inability to comply with study procedures including lack of telephone access for week 8 telephone survey
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660049

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Spiracur, Inc.
Investigators
Principal Investigator: Dr. Anne Lynn S. Chang Stanford University
  More Information

No publications provided

Responsible Party: Anne Chang, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00660049     History of Changes
Other Study ID Numbers: SU-02252008-1026, IRB Protocol #: 11074
Study First Received: April 4, 2008
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014