Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Description

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 Overview

Study Details

Study overview

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.

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Condition
Chronic Wounds
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona, Tucson, Arizona, United States, 85724

Cranberry Township

UPMC Wound Healing Services at UPMC Passavant, Cranberry Township, Pennsylvania, United States, 16066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Chandan K Sen, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2029-06-27