Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Wound Etiology and Healing Study (WE-HEAL)

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. Read our disclaimer for details. Identifier: NCT01352078
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : July 27, 2022
National Center for Research Resources (NCRR)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Victoria Shanmugam, MD, 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 743 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Wound Etiology and Healing Study
Study Start Date : May 2011
Actual Primary Completion Date : January 2022
Actual Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

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

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.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01352078

Layout table for location information
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
National Center for Research Resources (NCRR)
National Institute of Nursing Research (NINR)
Layout table for investigator information
Principal Investigator: Victoria K Shanmugam, MD George Washington University
Layout table for additonal information
Responsible Party: Victoria Shanmugam, MD, Professor, George Washington University Identifier: NCT01352078    
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: July 27, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victoria Shanmugam, MD, George Washington University:
Non healing ulcer
Hidradenitis suppurativa
Acne Inversa
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Wounds and Injuries
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious