Clinical trial NCT06328010: Clinical Registry Collecting Real World Evidence on Wound Care Treatments
Official title: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Keywords: Wound
DFU - Diabetic Foot Ulcer
VLU - Venous Leg Ulcer
Post Surgical
Trauma
Chronic Wound
MOHS - Mohs Micrographic Surgery
Non-Healing Wound
Lead sponsor: Siddhey LLC
Sponsor class: INDUSTRY
Collaborators: name: Acesso Biologics
First posted: 2024-03-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with wounds/injuries

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Data collection of 5000 wounds
timeFrame: Maximum of 12 weeks per wound treated
Secondary outcomes:
measure: Different types of wounds/injuries heal rate
timeFrame: per year up to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Venkatesh Ramaiah
state: Arizona
city: West Hills
country: United States
facility: West Hills Hospital and Medical Centers Doctors Suites
state: California
city: Durango
country: United States
facility: Innovation Medical Group
state: Colorado
city: Hialeah
country: United States
facility: Dr. Mario Adrian Cala, DPM
state: Florida
city: Miami
country: United States
facility: The Schottenstein Center
state: Florida
city: Miami
country: United States
facility: Dr. Mario Adrian Cala, DPM
state: Florida
city: North Miami Beach
country: United States
facility: Wigley Feet
state: Florida
Study officials:
References: