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_PRODUCT
    Treatments 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 Treatment
    Interventions 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)

FacilityCityStateZIPSite coordinators
Pulse Cardiovascular InstituteScottsdaleArizona85251-
Metro Foot & AnkleTempeArizona85282-
Pima Foot and Ankle Surgery LLCTucsonArizona85718-
Signature Health Medical GroupRiversideCalifornia92503-
The Schottenstein CenterHallandaleFlorida33009-
PerfectFeetCare Podiatry CentersHialeahFlorida33012-
PerfectFeetCare Podiatry CentersMiamiFlorida33175-
The Schottenstein CenterMiamiFlorida33137-
Wigley FeetNorth Miami BeachFlorida33162-
Rubin Foot & AnkleNapervilleIllinois60563-
The Rache ClinicLas VegasNevada89147-
Richard C. Galperin, DPM, PADallasTexas75208-

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