Clinical Registry Collecting Real World Evidence on Wound Care Treatments
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Siddhey LLC
- Study ID
- NCT06328010
- Status
- Enrolling By Invitation
Conditions
- Burns
- Degloving Injuries
- Diabetic Foot Ulcer Mixed
- Injury and Wounds
- Mohs Surgery
- Non-healing Wound
- Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trauma Injury
- Venous Leg Ulcer
- Wounds and Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Various types of wound care treatments — COMBINATION_PRODUCTTreatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based
Study Details
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.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2028
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Wound TreatmentInterventions are at the discretion of treating clinicians and include standard and advanced wound therapies.
Primary Outcome Measure
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale [ Time Frame: Up to 12 weeks ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pulse Cardiovascular Institute | Scottsdale | Arizona | 85251 | - |
| Metro Foot & Ankle | Tempe | Arizona | 85282 | - |
| Pima Foot and Ankle Surgery LLC | Tucson | Arizona | 85718 | - |
| Signature Health Medical Group | Riverside | California | 92503 | - |
| The Schottenstein Center | Hallandale | Florida | 33009 | - |
| PerfectFeetCare Podiatry Centers | Hialeah | Florida | 33012 | - |
| PerfectFeetCare Podiatry Centers | Miami | Florida | 33175 | - |
| The Schottenstein Center | Miami | Florida | 33137 | - |
| Wigley Feet | North Miami Beach | Florida | 33162 | - |
| Rubin Foot & Ankle | Naperville | Illinois | 60563 | - |
| The Rache Clinic | Las Vegas | Nevada | 89147 | - |
| Richard C. Galperin, DPM, PA | Dallas | Texas | 75208 | - |
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