RECRUITING

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Quick Facts

Study Start:2024-04-02
Study Completion:2029-06-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05172089

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female, Age ≥ 18
  2. * Willing to comply with protocol instructions, including all study visits and study activities.
  3. * Patient with an open Diabetic Foot Ulcer
  4. * Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):
  5. * TcOM \>30 mmHg
  6. * Ankle-brachial index ≥0.7-1.20
  7. * Toe pressure \> 30 mmHg
  8. * TBI \> 0.6 mmHg
  1. * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.
  2. * Wounds closed or to be surgically closed by flap or graft coverage
  3. * Subjects with marked immunodeficiency (HIV/AIDS, or on immunosuppressive medications.
  4. * TcOM \< 30mmHg
  5. * Diabetics with a hemoglobin A1c \> 12 within 3 months prior to enrollment
  6. * Subject with autoimmune connective tissue disease
  7. * Ulcer size and location that does not allow the TEWL measurement per SOP
  8. * Pregnant women
  9. * Prisoners
  10. * Unable to comply with study procedures and/or complete study visits

Contacts and Locations

Study Contact

Josephine Vidic, BS
CONTACT
4126240422
jbv9@pitt.edu
Piya Das Ghatak, PhD
CONTACT
4126240422
piya.dasghatak@pitt.edu

Principal Investigator

Chandan K Sen, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85724
United States
UPMC Wound Healing Services at UPMC Passavant
Cranberry Township, Pennsylvania, 16066
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Chandan K Sen, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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

Study Start Date2024-04-02
Study Completion Date2029-06-27

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2029-06-27

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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