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

Study Overview
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: ActiGraft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActiGraft<br>Whole blood clot (WBC) gel | Device: ActiGraft<br>* Whole blood clot (WBC) gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieving a Complete Wound Closure at 12 Weeks | Skin re-epithelialization without drainage or dressing requirements. | 12 weeks | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic, Ulcer, Lower extremity, DFU, VLU