Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT05172089

Conditions

Chronic Wounds

Biofilm Infection

Trans-epidermal Water Loss (TEWL)

Diabetic Foot

Diabetic Foot Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.

Conditions

Chronic Wounds

Biofilm Infection

Trans-epidermal Water Loss (TEWL)

Diabetic Foot

Diabetic Foot Infection

Study ID

NCT05172089

Start date

Apr 2, 2024

Status verified date

Mar, 2026

Completion date

Jun 27, 2029

Anticipated

Primary completion date

Jun 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female, Age ≥ 18
  • Willing to comply with protocol instructions, including all study visits and study activities.
  • Patient with an open Diabetic Foot Ulcer
  • Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):
  • TcOM >30 mmHg
  • Ankle-brachial index at least ≥0.7
  • Toe pressure > 30 mmHg
  • TBI > 0.6 mmHg

Exclusion Criteria:

  • Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
  • Wounds closed or to be surgically closed by flap or graft coverage
  • Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications.
  • TcOM < 30mmHg
  • Diabetics with a hemoglobin A1c > 15 within 3 months prior to enrollment
  • Subject with autoimmune connective tissue disease
  • Ulcer size and location that does not allow the TEWL measurement per SOP
  • Pregnant women
  • Prisoners
  • Unable to comply with study procedures and/or complete study visits

Study Design

Enrollment

405 participants

Anticipated

Interventions and Outcome Measures

Arms

Diabetic Foot Ulcer study

405 clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited . Wound swab for culture obtained. Baseline digital imaging of target wound(s). SF-12 Health survey, Visual Analogue Pain scale, Cardiff wound impact questionnaires. Wound site evaluation including TcOM/TBI/ankle brachial index (ABI) will be completed for subjects with wounds below the knee, if not already completed per standard of care within the previous 12 months. Hemoglobin A1c point of care testing will be drawn for diabetic subjects who do not have an A1c available within 90 days prior to enrollment; 3mm biopsy tissue or debrided tissue will be collected. Ideally, two tissue samples will be obtained; the subject's medical records will be reviewed and followed for up to 16 weeks or until their wound has closed, whichever comes first. The research staff will also call the patient or care facility as needed to check for wound closure.

Primary outcome measure

  • Biofilm infection abundance [ Time Frame: 16 weeks ]
  • TEWL [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Piya Das Ghatak, PhD, MS

4126240422piya.dasghatak@pitt.edu

Shomita S Steiner, PhD, MS

463•236•8770SSTEINER@pitt.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Fleur Maturo

520-621-8296fleurmartinez@arizona.edu

UPMC Wound Healing Services at UPMC Passavant

Recruiting

Cranberry Township, Pennsylvania, United States, 16066

Principal Investigator:

Chandan K Sen, Phd

More Information

Sponsor

University of Pittsburgh

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • foot ulcer
  • diabetic foot
  • wound infection
  • diabetic foot ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-03-18.