Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

Qualifiers

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

TcOM >30 mmHg

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

405 Participants
are grouped into 1 trial group

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

University of Arizona

Collaborator