Study of Biomarkers to Predict Healing in Diabetic Foot Ulcers Observational Research with Blood and Wound Sample Collection

What this Trial Is About

Researchers are studying diabetic foot ulcers DFUs to identify biomarkers that can predict which ulcers are more likely to heal. This observational platform study aims to improve personalized care decisions and enhance future clinical trials for wound healing. It includes patients with active DFUs seen in outpatient diabetic foot and wound care clinics across various healthcare settings. The study collects a wide range of data, including biospecimens and patient-reported outcomes, to better understand wound healing patterns and recurrence rates. The study does not involve any experimental treatments instead, participants receive usual clinical care at their respective clinics. Biospecimens collected include blood, wound fluid, wound dressings, and tissue from debridement if performed. Urine samples are also encouraged when possible. The study is flexible and can include additional biomarker-specific substudies. Participants may be enrolled in multiple substudies without needing new consent. Participants will be followed for up to 78 weeks, with visits every two weeks for the first month and monthly thereafter until the wound heals or up to week 52 if it does not. After healing, confirmation visits and assessments for ulcer recurrence occur via phone or video at weeks 52 and 78. Data collected includes wound healing status, infections, amputations, biospecimen quality, adherence to care, and physical and mental health scores. This comprehensive follow-up helps improve standards of care and supports personalized treatment approaches for DFUs.

DFC 004 Biomarkers for Active Diabetic Foot Ulcers