Autologous Regeneration of Tissue (ART) for Wound Healing

NCT03796988 | Completed Results FDA Device

• 1 other identifier: 20180154
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin

Keywords

Chronic Wound

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline, Day 56

• Time to Healing of Donor Sites

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

  Up to Day 56

Secondary Outcomes (2)

• Wound Healing of Recipient Site

  Up to Day 56

• Histologic Evaluation

  Up to Day 56

Study Arms (1)

Intervention arm

EXPERIMENTAL

The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.

Device: Autologous Regeneration of Tissue (ART) device

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• Medline Industries: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Reproductive Techniques, Assisted

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Hadar Lev-Tov, Assistant Professor
• Organization: University of Miami

hltevtov@med.miami.edu

305-243-4472

Study Officials

• Hadar Lev-Tov, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: September 14, 2018
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)