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Wound Etiology and Healing Study (WE-HEAL)

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ClinicalTrials.gov Identifier: NCT01352078
Recruitment Status : Recruiting
First Posted : May 11, 2011
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Victoria Shanmugam, George Washington University

Brief Summary:
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 or disease
Wounds Hidradenitis Suppurativa Hidradenitis Acne Inversa

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Wound Etiology and Healing Study
Study Start Date : May 2011
Estimated Primary Completion Date : June 2030
Estimated Study Completion Date : June 2040

Resource links provided by the National Library of Medicine


Group/Cohort
Non Healing Ulcer
Hidradenitis suppurativa



Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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
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Contact: Victoria K Shanmugam, MD 202-741-2488 vshanmugam@mfa.gwu.edu
Contact: Derek Jones 2027412488 derekjones@gwu.edu

Locations
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United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Victoria K Shanmugam, MD    202-741-2488    vshanmugam@mfa.gwu.edu   
Contact: Derek Jones    2027412488    derekjones@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
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Principal Investigator: Victoria K Shanmugam, MD George Washington University

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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 Posted: May 11, 2011    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by Victoria Shanmugam, George Washington University:
Non healing ulcer
Wound
Hidradenitis suppurativa
Acne Inversa
Hidradenitis
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Wounds and Injuries
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration