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NCT Number: NCT04699305

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

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

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Key information

Conditions

Cutaneous Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wound Care Experts

Las Vegas, Nevada, 89128, United States

Location status: Recruiting

Location contact

Naz Wahab, M.D

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ActiGraft

Device

Whole blood clot (WBC) gel

Primary outcomes

  1. Percentage area reduction (PAR) at 4 weeks

    Time frame: 4 weeks

    Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

  2. Nature, frequency, and severity of adverse events in the intent to treat population

    Time frame: 1 year

    Nature, frequency, and severity (by CTCAE5) of adverse events

Secondary outcomes

  1. Percentage area reduction at 8 and 12 weeks

    Time frame: 12 weeks

    Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

Other outcomes

  1. Reduction in pain at 4 weeks

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Sirota

CONTACT

[email protected]

+972545800765

Sponsors and collaborators

Lead sponsor

RedDress Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2021
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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