Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers
ConditionCutaneous Wounds
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRedDress Ltd.
About this trial
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subject/LAR is unable to read and understand English or Spanish.
Trial population
Patients with all types of exuding cutaneous wound
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
ActiGraft
DeviceWhole blood clot (WBC) gel
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: ActiGraft1 intervention
Trial outcomes
Primary outcomes
1
Percentage area reduction (PAR) at 4 weeks
Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).
Time frame
4 weeks2
Nature, frequency, and severity of adverse events in the intent to treat population
Nature, frequency, and severity (by CTCAE5) of adverse events
Time frame
1 yearSecondary outcomes
1
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).
Time frame
12 weeksOther outcomes
1
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
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov