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

RedDress

Status: Terminated

Conditions: Wounds

Treatments: Device: ActiGraft

Study type: Interventional

Funder types: Industry

Identifiers

NCT04745806

RD007

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

ActiGraft

Experimental group

Description:

Whole blood clot (WBC) gel

Treatment:

Device: ActiGraft