Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

Recruiting

• Conditions: Cutaneous Wounds

• Registration Number: NCT04699305
• Lead Sponsor: RedDress Ltd.

Brief Summary

Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-07-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subject is ≥18 years of age
• Subject has an exuding cutaneous wound
• Subject agrees to the use of his health data, including photos of his wound in analysis and publications
• Subject/LAR must be able to read and understand English and/or Spanish

Exclusion Criteria

• Subject/LAR is unable to read and understand English or Spanish.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nature, frequency, and severity of adverse events in the intent to treat population	1 year	Nature, frequency, and severity (by CTCAE5) of adverse events
Percentage area reduction (PAR) at 4 weeks	4 weeks	Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

Secondary Outcome Measures

Name	Time	Method
Percentage area reduction at 8 and 12 weeks	12 weeks	Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

Trial Locations

Locations (1)

Wound Care Experts; 🇺🇸 Las Vegas, Nevada, United States