Status:
TERMINATED
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
Lead Sponsor:
RedDress Ltd.
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04745806
Start Date
March 1 2021
End Date
January 1 2023
Last Update
November 15 2024
Active Locations (1)
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1
Emek Medical Center
Afula, Israel