Autologous Regeneration of Tissue (ART) for Wound Healing

University of Miami1 site in 1 country22 target enrollmentSeptember 14, 2018

ConditionsWound of Skin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wound of Skin
Sponsor: University of Miami
Enrollment: 22
Locations: 1
Primary Endpoint: Change of Pain on Harvesting of Skin at Donor Site.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 14, 2018

End Date

March 19, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Hadar Lev-Tov

Assistant Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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).