Study of Biofilm Infection and Skin Barrier Function in Diabetic Foot Ulcers and Their Impact on Wound Healing and Recurrence

What this Trial Is About

Diabetic foot ulcers DFU are a common and serious complication for people with type 2 diabetes, often leading to hospitalization and amputation. This research investigates whether DFUs with a history of biofilm infection heal with weakened skin barrier function and if this impaired healing, shown by high trans-epidermal water loss TEWL, increases the chance of wound recurrence. The study also explores the molecular mechanisms behind biofilm-related damage to skin barrier integrity in DFU patients. In this observational study, 405 patients with clinically diagnosed DFUs suspected of infection will be enrolled. Researchers will collect wound swabs for culture, take digital images of wounds, and perform assessments including health surveys and pain scales. Tests such as transcutaneous oxygen measurement, ankle-brachial index, and hemoglobin A1c will be conducted as needed. Tissue samples from the wound area will be collected to study biofilm presence. Participants will be followed for up to 16 weeks or until their wound closes. Participants will undergo regular evaluations including wound site checks and questionnaires on wound impact and pain. Monitoring involves reviewing medical records and contacting patients or care facilities to confirm wound closure. The primary outcomes being measured are biofilm infection levels at 16 weeks and TEWL at 12 weeks. This thorough monitoring aims to understand how biofilm infection affects wound healing and recurrence in diabetic foot ulcers.

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence