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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ActiGraft

Whole blood clot (WBC) gel

Group Type EXPERIMENTAL

ActiGraft

Intervention Type DEVICE

Whole blood clot (WBC) gel

Interventions

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ActiGraft

Whole blood clot (WBC) gel

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No