Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Pittsburgh
Study ID
NCT05172089
Status
Recruiting
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Conditions

  • Biofilm Infection
  • Chronic Wounds
  • Diabetic Foot
  • Diabetic Foot Infection
  • Trans-epidermal Water Loss (TEWL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 2, 2024
Status verified
Mar 2026
Primary completion
Jun 27, 2028
Completion
Jun 27, 2029

Study Design

Enrollment
405 participants (estimated)

Arms

  • Arm: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Fleur Maturo
[email protected]
520-621-8296
Geoffrey C. Gurtner, MD (SUB_INVESTIGATOR)
UPMC Wound Healing Services at UPMC PassavantCranberry TownshipPennsylvania16066
Chandan K Sen, Phd (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUPMC Wound Healing Services at UPMC Passavant· Cranberry Township, PA

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