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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745806
• Other study ID #: RD007
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2021
• Source: RedDress Ltd.
• Contact: Sahar Boostenay
• Phone: +972544621243
• Email: sboostenay[@]reddressmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wounds
• Wounds and Injuries

Intervention

Device:
• ActiGraft
Whole blood clot (WBC) gel

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
RedDress Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Achieving a Complete Wound Closure at 12 Weeks	Skin re-epithelialization without drainage or dressing requirements.	12 weeks
Secondary	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
Secondary	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
Secondary	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