Recruiting

ActiGraft

Sponsor:

RedDress Ltd.

Code:

NCT04699305

Conditions

Cutaneous Wounds

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ActiGraft

Study Details

Brief summary:

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

Conditions

Cutaneous Wounds

Study ID

NCT04699305

Start date

Feb 14, 2019

Status verified date

Jul, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

ActiGraft

Whole blood clot (WBC) gel

Interventions

ActiGraft

Whole blood clot (WBC) gel

Primary outcome measure

  • Percentage area reduction (PAR) at 4 weeks [ Time Frame: 4 weeks ]
  • Nature, frequency, and severity of adverse events in the intent to treat population [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sharon Sirota

+972545800765sharon@reddress.co.il

Locations

Wound Care Experts

Recruiting

Las Vegas, Nevada, United States, 89128

More Information

Sponsor

RedDress Ltd.

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • DFU, PU, Surgical, Vascular, Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RedDress Ltd. on 2025-07-29.