Wound Etiology and Healing Study

NCT01352078 | Completed

• 4 other identifiers: 041408KL2RR031974UL1RR031975R01NR013888
• Study Type: observational
• Target: 743
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wounds; Hidradenitis Suppurativa; Hidradenitis; Acne Inversa

Keywords

Non healing ulcer; Wound; Hidradenitis suppurativa; Acne Inversa; Hidradenitis

Outcome Measures

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.

  10 years

Study Arms (2)

Non Healing Ulcer

Hidradenitis suppurativa

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non healing wounds or hidradenitis suppurativa

You may qualify if:

• Age \>18
• Open wound or hidradenitis suppurativa
• English speaking
• Able to give informed consent

You may not qualify if:

• Non-English speaking.
• Unable to give informed consent

Sponsors & Collaborators

• George Washington University: lead
• National Center for Research Resources (NCRR): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

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

MeSH Terms

Conditions

Wounds and Injuries; Hidradenitis Suppurativa; Hidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Sweat Gland Diseases

Study Officials

• Victoria K Shanmugam, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 11, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)