Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Wound Etiology and Healing Study (WE-HEAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by George Washington University
Information provided by (Responsible Party):
Victoria Shanmugam, George Washington University Identifier:
First received: May 10, 2011
Last updated: September 23, 2014
Last verified: September 2014

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 in the Center for Wound Healing with an open wound are asked to participate. Information from this research may help to understand how to prevent and treat certain diseases.


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

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Time to wound healing [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 leg ulcers 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 2016 (Final data collection date for primary outcome measure)
Non Healing Ulcer


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Non healing wounds


Inclusion Criteria:

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

Exclusion Criteria:

  1. Non-English speaking.
  2. Unable to give informed consent
  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 identifier: NCT01352078

Contact: Victoria K Shanmugam, MD 202-741-2488
Contact: Sean McNish 202-994-8567

United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Victoria K Shanmugam, MD    202-741-2488   
Contact: Sean McNish    202-994-8567   
Principal Investigator: Victoria K Shanmugam, MD         
Sub-Investigator: Kara Couch, NP         
Sponsors and Collaborators
George Washington University
Principal Investigator: Victoria K Shanmugam, MD George Washington University
  More Information

No publications provided

Responsible Party: Victoria Shanmugam, Associate Professor of Medicine, George Washington University Identifier: NCT01352078     History of Changes
Other Study ID Numbers: 041408, KL2RR031974, UL1RR031975, R01NR013888
Study First Received: May 10, 2011
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Non healing ulcer
Wound processed this record on February 27, 2015