Wound Etiology and Healing Study (WE-HEAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Georgetown University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Vicki Shanmugam, Georgetown University
ClinicalTrials.gov Identifier:
NCT01352078
First received: May 10, 2011
Last updated: August 6, 2013
Last verified: August 2013

May 10, 2011
August 6, 2013
May 2011
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01352078 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Wound Etiology and Healing Study
The Wound Etiology and Healing Study

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  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.
Non-Probability Sample

Non healing wounds

Wounds
Not Provided
Non Healing Ulcer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2021
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Victoria K Shanmugam, MD 202-444-6200 vks4@gunet.georgetown.edu
Contact: Sean McNish 202-444-6200 sm965@georgetown.edu
United States
 
NCT01352078
2011-055, KL2RR031974, UL1RR031975, R01NR013888
No
Vicki Shanmugam, Georgetown University
Georgetown University
  • National Center for Research Resources (NCRR)
  • National Institute of Nursing Research (NINR)
Principal Investigator: Victoria K Shanmugam, MD Georgetown University Hospital
Georgetown University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP