Clinical Registry Collecting Real World Evidence on Wound Care Treatments (SIDDX)

Siddhey

Status: Invitation-only

Conditions: Venous Leg Ulcer; Pressure Ulcers, Bedsores, Decubitus Ulcer; Diabetic Foot Ulcer Mixed; Trauma Injury; Mohs Surgery; Burns; Degloving Injuries; Non-healing Wound; Wounds and Injuries; Injury and Wounds

Treatments: Other: Retrospective wound treatment data collection; Biological: Advanced Treatment Modalities for wound and injuries; Biological: Standard of care

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06328010

SIDDXAC02

Details and patient eligibility

About

Collect data on various wound/injuries treatments and their related wound healing process, in real life settings. Over a 12-week period per wound treated.

Analyze the safety and efficacy of wound treatments, including advanced biological/synthetic grafts with designations of 361 HCT/Ps or 510(k) FDA clearance and standard of care wound treatments.

Full description

This clinical registry is an observational study to collect prospective and retrospective data on subject 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. Structured data including wound photos are to be collected at the point of care in the subject electronic Case Report Form. The registry will enroll data of up to 5000 wounds in up to 50 wound care locations. The dataset includes all wound/injuries and ulcer types.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 3 patient groups

Wound Treatment with Advanced Therapies

Description:

Only treatments with advanced therapies, post standard care (SOC).

Treatment:

Biological: Advanced Treatment Modalities for wound and injuries

Wound Treatment with Standard of Care

Description:

Only treatments with SOC, no human derived biological grafting treatments, no hyperbaric treatment, no synthetic grafting treatment, and no animal product biological grafting treatment.

Treatment:

Biological: Standard of care

Retrospective wound care treatment and heal times

Description:

Only retrospective wound care treatment data irrelevant to treatment modality.

Treatment:

Other: Retrospective wound treatment data collection