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

Cutaneous Wounds Clinical Trial

Official title:

An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699305
• Other study ID #: RD005
• Status: Recruiting
• Start date: February 14, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: August 2023
• Source: RedDress Ltd.
• Contact: Sharon Sirota
• Phone: +972545800765
• Email: sharon[@]reddress.co.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2026
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Wounds
• Wounds and Injuries

Intervention

Device:
• ActiGraft
Whole blood clot (WBC) gel

Locations

Country	Name	City	State
United States	Wound Care Experts	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
RedDress Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in pain at 4 weeks	Pain reduction at 4 weeks for wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT) for patients reporting any level of wound related pain (>1 on a VAS scale of 0-10 points) at baseline	4 weeks
Primary	Percentage area reduction (PAR) at 4 weeks	Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).	4 weeks
Primary	Nature, frequency, and severity of adverse events in the intent to treat population	Nature, frequency, and severity (by CTCAE5) of adverse events	1 year
Secondary	Percentage area reduction at 8 and 12 weeks	Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).	12 weeks