NCT03796988

Autologous Regeneration of Tissue (ART) for Wound Healing

Completed NA Results posted Last updated 23 April 2025

What this trial tests

NA trial testing Autologous Regeneration of Tissue (ART) device in Wound of Skin in 22 participants. Completed in 19 March 2024.

Timeline

14 September 2018

Primary endpoint
19 March 2024

19 March 2024

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	14 September 2018
Primary completion	19 March 2024
Estimated completion	19 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Autologous Regeneration of Tissue (ART) device

Conditions studied

• Wound of Skin — all drugs for Wound of Skin →

Sponsor

University of Miami

Who can join

Adults 18 to 90, any sex, with Wound of Skin. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change of Pain on Harvesting of Skin at Donor Site. Primary · 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)

Group	Value	95% CI
Intervention Arm	2.6	± 5.9

Time to Healing of Donor Sites Primary · 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.

Group	Value	95% CI
Intervention Arm	24	± 17

Wound Healing of Recipient Site Secondary · Up to Day 56

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

Group	Value	95% CI
Intervention Arm	-3.6	± 16.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (5 terms — click to expand)

Reaction	System	Intervention Arm
Bruising	Injury, poisoning and procedural complications	—
Skin Infection	Infections and infestations	—
Skin Infections	Infections and infestations	—
Skin Infections	Infections and infestations	—
Respiratory Infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT03796988 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.