Trials / Enrolling By Invitation
Enrolling By InvitationNCT06328010
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Siddhey LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Wounds and Injuries
- Burns
- Mohs Surgery
- Diabetic Foot Ulcer Mixed
- Venous Leg Ulcer
- Non-healing Wound
- Trauma Injury
- Injury and Wounds
- Degloving Injuries
- Pressure Ulcers, Bedsores, Decubitus Ulcer
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Various types of wound care treatments | Treatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2028-12-31
- Completion
- 2030-06-30
- First posted
- 2024-03-25
- Last updated
- 2026-03-11
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06328010. Inclusion in this directory is not an endorsement.