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Wound Etiology and Healing Study (WE-HEAL)

This study is currently recruiting participants.
Verified May 2012 by Georgetown University
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Vicki Shanmugam, Georgetown University
ClinicalTrials.gov Identifier:
NCT01352078
First received: May 10, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  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 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.


Condition
Wounds

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 Georgetown 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 biopsy 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.

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)
Groups/Cohorts
Non Healing Ulcer

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352078

Contacts
Contact: Victoria K Shanmugam, MD 202-444-6200 vks4@gunet.georgetown.edu
Contact: Sean McNish 202-444-6200 sm965@georgetown.edu

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Victoria K Shanmugam, MD     202-444-6200     vks4@gunet.georgetown.edu    
Contact: Sean McNish     202-444-6200     sm965@georgetown.edu    
Principal Investigator: Victoria K Shanmugam, MD            
Sub-Investigator: Christopher E Attinger, MD            
Sub-Investigator: Paul Kim, DPM            
Sub-Investigator: John Steinberg, DPM            
Sub-Investigator: David Garvin, MD            
Sub-Investigator: Bhaskar Kallakury, MD            
Sub-Investigator: Karen Kim Evans, MD            
Sub-Investigator: Anton Wellstein, MD, PhD            
Sponsors and Collaborators
Georgetown University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Victoria K Shanmugam, MD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Vicki Shanmugam, Assistant Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT01352078     History of Changes
Other Study ID Numbers: 2011-055, KL2RR031974, UL1RR031975
Study First Received: May 10, 2011
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Non healing ulcer
Wound

ClinicalTrials.gov processed this record on May 23, 2013