The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
This clinical registry is an observational study to collect prospective and retrospective data on subjects' health, wounds and wound care procedures from medical centers, including skilled nursing facilities, hospitals, outpatient clinics, Home Health and any other medical environment where wounds are treated. The registry will enroll data of up to 5000 subjects in up to 100 wound care locations. The dataset includes all wound and ulcer types. Investigators will follow Institutional standards for routine wound care practices. The study products supplied through this study will be applied to the wounds as an adjunct to the standard of care treatment.
Study Type
OBSERVATIONAL
Enrollment
5,000
Treatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based
Pulse Cardiovascular Institute
Scottsdale, Arizona, United States
Metro Foot & Ankle
Tempe, Arizona, United States
Pima Foot and Ankle Surgery LLC
Tucson, Arizona, United States
Signature Health Medical Group
Riverside, California, United States
The Schottenstein Center
Hallandale, Florida, United States
PerfectFeetCare Podiatry Centers
Hialeah, Florida, United States
The Schottenstein Center
Miami, Florida, United States
PerfectFeetCare Podiatry Centers
Miami, Florida, United States
Wigley Feet
North Miami Beach, Florida, United States
Rubin Foot & Ankle
Naperville, Illinois, United States
...and 2 more locations
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale
Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)
Time frame: Up to 12 weeks
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events (AEs) related to wounds, and device-related adverse events (DRAEs)
Note: Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)
Time frame: Up to 12 weeks
Proportion of wounds achieving complete closure over time
Time frame: Up to 12 weeks
Time to achieve complete wound closure while receiving study product
Time frame: Up to 12 weeks
Assessment of patient reported wound-related pain using a numeric pain rating scale of 0 (no pain) to 10 (worst possible pain) during study product application
Time frame: Up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.