ART Device for Skin Wound Healing

Overseen By Aliette Espinosa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Antimicrobials, Immunosuppressants, Cytotoxics

Disqualifiers: Pregnancy, Peripheral arterial disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Autologous Regeneration of Tissue (ART) to heal skin wounds using a person's own skin. The ART device collects skin from a donor area on the body and places it on the wound to aid healing. This approach may suit individuals with a chronic wound lasting at least 30 days. Participants must consent to join the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from cutting-edge treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic antimicrobials, immunosuppressive agents, or treatments for certain cancers, you may not be eligible to participate.

What prior data suggests that the ART device is safe for skin wound healing?

Research has shown that the Autologous Regeneration of Tissue (ART) device safely and effectively collects skin for grafts. Studies indicate that this device causes little to no pain, and the skin heals quickly with minimal scarring. The ART device is minimally invasive, requiring little cutting or damage to the skin, which usually results in fewer side effects and a quicker recovery.

Other studies on similar technology for skin healing have demonstrated improved wound healing rates, suggesting that the ART device is well-tolerated. Additionally, the ART Skin Harvesting System has been reviewed for safety and effectiveness in collecting skin grafts.

Overall, research suggests that the ART device is safe for people, focusing on reducing pain and speeding up healing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ART device is unique because it uses a patient's own skin to promote healing in wounds, a process known as autologous regeneration. Unlike standard treatments, which often rely on synthetic materials or donor skin, this method involves harvesting skin from the patient and applying it to the wound site. This approach not only reduces the risk of rejection but also encourages natural tissue growth and repair. Researchers are excited about the potential for faster healing times and improved outcomes, as the body's own cells are used to regenerate damaged tissue.

What evidence suggests that the ART device is effective for skin wound healing?

Research has shown that the Autologous Regeneration of Tissue (ART) device holds promise for healing skin wounds. In this trial, participants will receive treatment using the ART device, which uses the patient's own skin to create tiny skin columns, aiding in wound healing with less pain and scarring. Previous studies have found that this method can be effective for chronic wounds that resist regular treatments. Animal studies also support its potential, demonstrating successful skin grafting with the ART system. Overall, early findings suggest that the ART device could offer a more effective and less painful way to treat skin wounds. ^{1 2 3 5 6}

Who Is on the Research Team?

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with chronic wounds present for at least 30 days. Participants must be able to consent and cannot have leg lesions, significant arterial disease, need cancer treatment (except certain skin cancers), or be on immunosuppressants, radiation, cytotoxic agents. Pregnant women and those with conditions that may risk safety or study goals are excluded.

Inclusion Criteria

You have a wound that has been present for at least 30 days and has not healed.

Able and willing to give consent for the study

Exclusion Criteria

You have leg wounds or serious blockages in your leg arteries that have not been treated.

You are currently receiving treatment for any type of cancer, except for certain types of skin cancer.

Subjects requiring concurrent systemic antimicrobials during the study period for any infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The donor area is anesthetized, harvested with the ART device, and bandaged. The harvested skin is placed on the recipient wound area and bandaged.

8 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Regeneration of Tissue (ART) device

Trial Overview The study is testing a new device called Autologous Regeneration of Tissue (ART) designed to collect skin grafts from the patient's own body to help heal chronic wounds.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Medline Industries

Industry Sponsor

Trials

46

Recruited

23,000+

Citations

1. jaad.org jaad.org/article/S0190-9622(25)01261-7/fulltext

63068 Autologous Regeneration of Tissue (ART) for ... This study explores a novel autologous regeneration of tissue (ART) device designed to harvest and use microscopic full-thickness skin columns to enhance wound ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03368534

Autologous Regenerative Technology (ART) For Wound ... The purpose of the study is to provide a more effective method of harvesting skin with minimal or no pain, heal more rapidly with little scarring in an ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11310043/

Efficacy of autologous micrografts technology This study explores the efficacy of Autologous Micrografts Technology (AMG) in treating chronic wounds refractory to traditional therapies.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210049.pdf

DEN210049, Medline ART Skin Harvesting System, Medline ... The ART (Autologous Regeneration of Tissue) Skin Harvesting System is intended for the harvesting and application of autologous, full thickness micro grafts ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11649333/

Application of a minimally invasive full‐thickness ... Using a 6‐week porcine full‐thickness excisional wound grafting model, we evaluated the Autologous Regeneration of Tissue (ART®) System, a novel ...

6. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04425-z

Efficacy and safety of epidermal cell regeneration for ... The results of this study demonstrate that autologous epidermal regeneration technology significantly improves wound healing rates at 3 ...