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

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ClinicalTrials.gov Identifier: NCT04699305
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
RedDress Ltd.

Study Description
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Brief Summary:
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.

Condition or disease Intervention/treatment
Cutaneous Wounds Device: ActiGraft

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 28, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
ActiGraft
Whole blood clot (WBC) gel
 Device: ActiGraft
Whole blood clot (WBC) gel


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with all types of exuding cutaneous wound
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699305


Contacts
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Contact: Sharon Sirota +972545800765 sharon@reddress.co.il

Locations
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United States, Nevada
Wound Care Experts Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Naz Wahab, M.D         
Sponsors and Collaborators
RedDress Ltd.
Investigators
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Study Director: Sharon Sirota RedDress Ltd.
More Information
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Responsible Party: RedDress Ltd.
ClinicalTrials.gov Identifier: NCT04699305    
Other Study ID Numbers: RD005
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results will be part of several scientific publications
Supporting Materials: Study Protocol
Time Frame: Upon publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by RedDress Ltd.:
DFU, PU, Surgical, Vascular, Trauma
Additional relevant MeSH terms:
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Wounds and Injuries