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CompletedNCT01352078WE-HEALUpdated Jul 27, 2022

Wound Etiology and Healing Study

An observational study in Wounds, Hidradenitis Suppurativa and Hidradenitis, sponsored by George Washington University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by George Washington University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
743
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wounds
  • Hidradenitis Suppurativa
  • Hidradenitis
  • Acne Inversa

Keywords

  • Non healing ulcer
  • Wound
  • Hidradenitis suppurativa
  • Acne Inversa
  • Hidradenitis
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 743 is above the median of 142 across 69 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

Exclusion Criteria:

  1. Non-English speaking.
  2. Unable to give informed consent
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
743 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Non Healing Ulcer
  • Hidradenitis suppurativa
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 years

07

Study locations

1 site
  • George Washington University
    Washington, District of Columbia 20037, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01352078
Lead sponsor
George Washington University
Collaborators
National Center for Research Resources (NCRR), National Institute of Nursing Research (NINR)
Responsible party
Victoria Shanmugam, MD (Professor, George Washington University) — Principal investigator
First posted
May 11, 2011
Start date
May 2011
Primary completion
Jan 2022
Completion
Jan 2022
Last update
Jul 27, 2022

Study contacts

Victoria K Shanmugam, MD
principal investigator · George Washington University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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