Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds

A Prospective, Single Arm, Post Marketing Study for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard to Heal Wounds

The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.

Study Overview

• Status: Recruiting
• Conditions: Wounds
• Intervention / Treatment: Device: ActiGraft

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sahar Boostenay; Phone Number: +972544621243; Email: sboostenay@reddressmedical.com
• Study Contact Backup: Name: Sharon Sirota; Phone Number: +972545800765; Email: sharon@reddress.co.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Emek Medical Center
    • Contact: Rotem Swartzman; Phone Number: +972-52-5935391; Email: rotem_sw@clalit.org.il
    • Principal Investigator: Aziz Shoufani, Dr. Med.
    • Sub-Investigator: Tamar Halperin, Dr. Med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is ≥18 years of age
2. Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
3. Ulcer duration >30 days.
4. Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
5. Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
6. Subject can read and understand the Informed Consent form

Exclusion Criteria:

1. Presence of active underlying osteomyelitis.
2. Known malignancy in the reference wound bed or margins of the wound
3. Cannot withdraw blood in the required amount technically.
4. Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
5. Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
6. Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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
Percent of Reduction in Wound Size Over 12 Weeks	The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.	4, 8, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Achieving a Complete Wound Closure at 12 Weeks	Skin re-epithelialization without drainage or dressing requirements.	12 weeks
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks	Skin re-epithelialization without drainage or dressing requirements.	18 and 24 weeks
Percent of Reduction in Wound Size Over 18 and 24 Weeks.	The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage for wound treated beyond 12 weeks, per the investigator's decision	18 and 24 weeks
The change in wound pain by 12 weeks	Pain assessment would be done by using the Numeric Rating Scale (NRS). Subject chooses a number on a 1 to 10 scale that best describes his ulcer pain, while 0 represents "No Pain" and 10- " Worst Pain Imaginable "test, a scale between .	12 weeks

Collaborators and Investigators

• Sponsor: RedDress Ltd.
• Investigators: Study Director: Sharon Sirota, RedDress Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: DFU; Chronic; Ulcer; Lower extremity; VLU
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RD007

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: No
• product manufactured in and exported from the U.S.: No