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

August 11, 2023 updated by: RedDress Ltd.

An Observational Clinical Registry to Collect Safety and Efficacy Data on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Wound Care Experts
        • Contact:
          • Naz Wahab, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with all types of exuding cutaneous wound

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ActiGraft
Whole blood clot (WBC) gel
Device: ActiGraft
Whole blood clot (WBC) gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 weeks
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RedDress Ltd.

Investigators

  • Study Director: Sharon Sirota, RedDress Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2019

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results will be part of several scientific publications

IPD Sharing Time Frame

Upon publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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