Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

NCT05172089 | Recruiting DMC

• 2 other identifiers: STUDY230501163R01DK125835-02S1
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 2

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

Keywords

foot ulcer; diabetic foot; wound infection; diabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

• Biofilm infection abundance

  Test the incidence of wound biofilm infection at initial visit and test its association with deficient skin barrier function at the closed DFU-site

  16 weeks

• TEWL

  Trans epidermal water loss post closure and 12 weeks

  12 weeks

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

clinically diagnosed Diabetic Foot Ulcer (DFU) patients who are suspected to be infected will be recruited for this larger cohort of patients in the parent study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Arizona: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

UPMC Wound Healing Services at UPMC Passavant

Cranberry Township, Pennsylvania, 16066, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Wound debridement collection: Debridement of tissue will be conducted as a standard of care (SoC) procedure for these patients. This debrided tissue would normally be disposed of as waste tissue, but for this study the investigators will collect this discarded waste tissue and perform analysis. In brief, waste tissue from debridement of the wound edge will be collected for histology molecular biology and immunohistochemistry studies. Samples will be used to determine whether the wound is infected using standard lab techniques.

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Wound Infection

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Infections

Study Officials

• Chandan K Sen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piya Das Ghatak, PhD, MS

CONTACT

4126240422; piya.dasghatak@pitt.edu

Shomita S Steiner, PhD, MS

CONTACT

463•236•8770; SSTEINER@pitt.edu

Study Design

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

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 29, 2021
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 27, 2028
• Study Completion (Estimated): June 27, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (2)