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Wound Etiology and Healing Study (WE-HEAL)

This study is currently recruiting participants.
Verified August 2017 by Victoria Shanmugam, George Washington University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352078
First Posted: May 11, 2011
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Center for Research Resources (NCRR)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Victoria Shanmugam, George Washington University
  Purpose
The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health records to study the reasons why some patients heal quickly and some have problems healing wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to participate. Information from this research may help to understand how to prevent and treat certain diseases.

Condition
Wounds Hidradenitis Suppurativa Hidradenitis Acne Inversa

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Wound Etiology and Healing Study

Resource links provided by NLM:


Further study details as provided by Victoria Shanmugam, George Washington University:

Primary Outcome Measures:
  • Time to wound healing [ Time Frame: 10 years ]
    This prospective study will establish a biobank for collection of residual biopsy tissue discarded after debridement, and collection of other biospecimens at the discretion of the investigators including wound fluid and serum samples. Patients will also permit linking of biosamples to clinical outcomes data. Using a primary outcome of wound healing we will compare biomarkers on tissue, serum and wound fluid from patients with non-healing ulcers and hidradenitis to identify angiogenic and vasculogenic pathways that are dysregulated in patients with wound healing problems.


Biospecimen Retention:   Samples With DNA
  1. Residual tissue left over after routine debridement surgery
  2. Wound fluid that would otherwise be discarded
  3. Residual blood/ serum samples left over after pre-surgery blood tests have been performed.
  4. Wound biofilm
  5. Wound photographs

Estimated Enrollment: 1000
Study Start Date: May 2011
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non Healing Ulcer

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non healing wounds or hidradenitis suppurativa
Criteria

Inclusion Criteria:

  1. Age >18
  2. Open wound or hidradenitis suppurativa
  3. English speaking
  4. Able to give informed consent

Exclusion Criteria:

  1. Non-English speaking.
  2. Unable to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352078


Contacts
Contact: Victoria K Shanmugam, MD 202-741-2488 vshanmugam@mfa.gwu.edu
Contact: Sean McNish 202-994-8567 mcnish@gwu.edu

Locations
United States, District of Columbia
George Washington University Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Victoria K Shanmugam, MD    202-741-2488    vshanmugam@mfa.gwu.edu   
Contact: Sean McNish    202-994-8567    mcnish@gwu.edu   
Principal Investigator: Victoria K Shanmugam, MD         
Sponsors and Collaborators
George Washington University
National Center for Research Resources (NCRR)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Victoria K Shanmugam, MD George Washington University
  More Information

Responsible Party: Victoria Shanmugam, Associate Professor of Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT01352078     History of Changes
Other Study ID Numbers: 041408
KL2RR031974 ( U.S. NIH Grant/Contract )
UL1RR031975 ( U.S. NIH Grant/Contract )
R01NR013888 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2011
First Posted: May 11, 2011
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Victoria Shanmugam, George Washington University:
Non healing ulcer
Wound
Hidradenitis suppurativa
Acne Inversa
Hidradenitis

Additional relevant MeSH terms:
Wounds and Injuries
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration