Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence
Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (\>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection poses to the non-healing DFU. Biofilms are estimated to account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. Thus, standard clinical techniques like the colony forming unit (CFU) assay to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care.
Conditions:
🦠 Chronic Wounds 🦠 Biofilm Infection 🦠 Trans-epidermal Water Loss (TEWL) 🦠 Diabetic Foot 🦠 Diabetic Foot Infection
🗓️ Study Start (Actual) 2 April 2024
🗓️ Primary Completion (Estimated) 27 June 2027
✅ Study Completion (Estimated) 27 June 2029
👥 Enrollment (Estimated) 405
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Tucson, Arizona, United States
📍 Cranberry Township, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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 ≥0.7-1.20
    • * 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 \> 12 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 December 2021
  • First Submitted that Met QC Criteria 12 December 2021
  • First Posted 29 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 19 April 2024
  • Last Verified April 2024