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Tissue Regeneration

ART Device for Skin Wound Healing

N/A
Waitlist Available
Led By Hadar Lev-Tov, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 56
Awards & highlights

Study Summary

This trial is testing a new device that takes skin grafts from a person's own skin.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects might include discomfort at the graft collection site, infection risks due to open wounds, possible allergic reactions to materials in the ART device, and complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a wound that has been present for at least 30 days and has not healed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of pain on harvesting of skin at donor site.
Time to healing of donor sites
Secondary outcome measures
Histologic evaluation
Wound healing of recipient site

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,230 Total Patients Enrolled
Medline IndustriesIndustry Sponsor
45 Previous Clinical Trials
23,011 Total Patients Enrolled
Hadar Lev-Tov, MDPrincipal Investigator - University of Miami
University of Miami Hospital
8 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Autologous Regeneration of Tissue (ART) device (Tissue Regeneration) Clinical Trial Eligibility Overview. Trial Name: NCT03796988 — N/A
Skin Wound Research Study Groups: Intervention arm
Skin Wound Clinical Trial 2023: Autologous Regeneration of Tissue (ART) device Highlights & Side Effects. Trial Name: NCT03796988 — N/A
Autologous Regeneration of Tissue (ART) device (Tissue Regeneration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796988 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for someone to enroll in this experiment?

"In order to participate in this research trial, volunteers must possess a skin wound and be aged between 18-90. Currently, the study is seeking approximately 30 individuals for its experiment."

Answered by AI

Is this research open to participants who are over 20 years old?

"According to the requirements of this research, applicants must be 18 years or older, while not exceeding 90 years old."

Answered by AI

Is access to this clinical investigation currently available for participants?

"As per the details provided on clinicaltrials.gov, this research endeavour is no longer accepting participants at present. Originally posted in September of 2018 and last edited May 27th 2022, it does not currently require any more test subjects despite 743 other studies recruiting actively."

Answered by AI
~5 spots leftby Mar 2025