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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01352078
Other study ID # 041408
Secondary ID KL2RR031974UL1RR
Status Completed
Phase
First received
Last updated
Start date May 2011
Est. completion date January 2022

Study information

Verified date July 2022
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 743
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States George Washington University Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
George Washington University National Center for Research Resources (NCRR), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to wound healing 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. 10 years
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