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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called ART that helps collect skin grafts from a patient's own skin. It is aimed at people who need skin grafts, such as those with burns or injuries. The device works by growing new skin from a small sample of the patient's own skin, which can then be used for healing.

Research Team

Hadar Lev-Tov, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Adults from 18 to 90 years of age

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

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

Treatment Details

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.

Participant Groups

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+