Autologous Regeneration of Tissue (ART) for Wound Healing

Wound of Skin Clinical Trial

Official title:

Autologous Regeneration of Tissue (ART) for Wound Healing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03796988
• Other study ID #: 20180154
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Wound of Skin
• Wounds and Injuries

Intervention

Device:
• Autologous Regeneration of Tissue (ART) device
This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (no pain) to 10 (worst possible pain)	Baseline, Day 56
Primary	Time to healing of donor sites	At each weekly visit, the donor site will be assessed for wound area in cm^2	Up to Day 56
Secondary	Wound healing of recipient site	At each weekly visit, the recipient area will be assessed for healing area percentage	Up to Day 56
Secondary	Histologic evaluation	As measured by tissue samples from biopsy	Up to Day 56