Clinical Registry Collecting Real World Evidence on Wound Care Treatments

Launched by SIDDHEY LLC · Mar 18, 2024

Keywords

ClinConnect Summary

This is an observational wound-care registry called SIDDX. Researchers will collect real-world data on how different wound treatments work in everyday clinical settings, including advanced therapies like grafts and standard care. They plan to track up to 5,000 wounds across about 50 wound-care locations, following each wound for up to 12 weeks to see how quickly it heals and to compare advanced treatments with standard care. The study isn’t testing a single new treatment; it’s watching what happens in real life to learn about safety and effectiveness.

Who can participate: adults 18 and older (up to 90 years) who have a wound or ulcer, such as a diabetic foot ulcer, venous leg ulcer, pressure ulcer, burn, trauma, or a post-surgical wound. People must be able to read and understand English or Spanish and agree to share their health information and wound photos for analysis. If you join, you’ll receive care at participating centers as you normally would, and clinicians will collect routine data from your visits for the registry. The study is currently enrolling by invitation at several U.S. sites, with plans to follow wounds over time and across different conditions, and to monitor safety as data are gathered.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects are 18 years of age or older.
• • 2. Subject has an ulcer (Diabetic foot ulcer, Venous stasis ulcer, etc.), injury (trauma, post -surgical, MOHS treatment), Burns injury, and acute/chronic wounds.
• • 3. Subject agrees to the use of his health data, including photos of his wound in analysis and publications.
• • 4. Subject/LAR must be able to read and understand English and/or Spanish.
• Exclusion Criteria:
• • 1. Subject/LAR is unable to read and understand English or Spanish.