Status:
COMPLETED
Autologous Regeneration of Tissue (ART) for Wound Healing
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Medline Industries
Conditions:
Wound of Skin
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.
Eligibility Criteria
Inclusion
- Adults from 18 to 90 years of age.
- Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
- Able and willing to give consent for the study.
Exclusion
- Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
- Adults unable to consent.
- Prisoners.
- Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
- Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
- Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
- Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
- Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Key Trial Info
Start Date :
September 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03796988
Start Date
September 14 2018
End Date
March 19 2024
Last Update
April 23 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136