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Completed

NCT Number: NCT03796988

Autologous Regeneration of Tissue (ART) for Wound Healing

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.

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Key information

Conditions

Wound of Skin

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Autologous Regeneration of Tissue (ART) device

Device

This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.

Primary outcomes

  1. Change of Pain on Harvesting of Skin at Donor Site.

    Time frame: Baseline, Day 56

    Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 millimeters (no pain) to 100 millimeters (worst possible pain)

  2. Time to Healing of Donor Sites

    Time frame: Up to Day 56

    At each weekly visit, the donor site will be assessed for healing based on clinical observation as measured by number of days from procedure.

Secondary outcomes

  1. Wound Healing of Recipient Site

    Time frame: Up to Day 56

    At each weekly visit, the recipient area will be assessed for healing area percentage

  2. Histologic Evaluation

    Time frame: Up to Day 56

    As measured by tissue samples from biopsy

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Medline Industries

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2019
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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