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

NCT04745806 | Terminated

• 1 other identifier: RD007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wounds

Keywords

Chronic; Ulcer; Lower extremity; DFU; VLU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Achieving a Complete Wound Closure at 12 Weeks

  12 weeks

• Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks

  18 and 24 weeks

• Percent of Reduction in Wound Size Over 18 and 24 Weeks.

  18 and 24 weeks

• The change in wound pain by 12 weeks

  12 weeks

Study Arms (1)

ActiGraft

EXPERIMENTAL

Whole blood clot (WBC) gel

Device: ActiGraft

Interventions

ActiGraft DEVICE

Whole blood clot (WBC) gel

ActiGraft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of active underlying osteomyelitis.
• Known malignancy in the reference wound bed or margins of the wound
• Cannot withdraw blood in the required amount technically.
• Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
• Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
• 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

Sponsors & Collaborators

• RedDress Ltd.: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries; Bronchiolitis Obliterans Syndrome; Ulcer

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon Sirota

  RedDress Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication.

Locations

IL (1)