Clinical Registry Collecting Real World Evidence on Wound Care Treatments

• Conditions: Wounds and Injuries; Non-healing Wound; Burns; Venous Leg Ulcer; Mohs Surgery; Trauma Injury; Diabetic Foot Ulcer Mixed; Injury and Wounds; Degloving Injuries; Pressure Ulcers, Bedsores, Decubitus Ulcer
• Interventions: Biological: Advanced Treatment Modalities for wound and injuries; Biological: Standard of care; Other: Retrospective wound treatment data collection

• Registration Number: NCT06328010
• Lead Sponsor: Siddhey LLC

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.

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Study Start: 2024-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Primary Completion: 2028-12-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wound Treatment with Advanced Therapies	Advanced Treatment Modalities for wound and injuries	Only treatments with advanced therapies, post standard care (SOC).
Wound Treatment with Standard of Care	Standard of care	Only treatments with SOC, no human derived biological grafting treatments, no hyperbaric treatment, no synthetic grafting treatment, and no animal product biological grafting treatment.
Retrospective wound care treatment and heal times	Retrospective wound treatment data collection	Only retrospective wound care treatment data irrelevant to treatment modality.

Primary Outcome Measures

Name	Time	Method
Data collection of 5000 wounds	Maximum of 12 weeks per wound treated	ONLY Advanced Treatment Therapies VS Rate of Healing

Secondary Outcome Measures

Name	Time	Method
Different types of wounds/injuries heal rate	per year up to 5 years	Segregate data by etiology vs rate of healing, ethnicity vs rate of healing, other medical conditions and treatment vs rate of healing

Trial Locations

Locations (6)

West Hills Hospital and Medical Centers Doctors Suites; 🇺🇸 West Hills, California, United States

Venkatesh Ramaiah; 🇺🇸 Scottsdale, Arizona, United States

Dr. Mario Adrian Cala, DPM; 🇺🇸 Miami, Florida, United States

The Schottenstein Center; 🇺🇸 Miami, Florida, United States

Innovation Medical Group; 🇺🇸 Durango, Colorado, United States

Wigley Feet; 🇺🇸 North Miami Beach, Florida, United States