Autologous Regenerative Technology (ART) For Wound Healing

NCT03368534 | Withdrawn FDA Device

• 1 other identifier: 42628
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 outpatient setting with the use of only local anesthesia.

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (11)

• Patient-reported pain at skin donor site at Day 7

  Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)

  Day 7

• Patient-reported pain at skin donor site at Day 14

  Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)

  Day 14

• Patient-reported pain at skin donor site at Day 21

  Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)

  Day 21

• Patient-reported pain at skin donor site at Day 28

  Pain will be assessed on an 11-point visual analogue scale (range 0 to 10, with 0 corresponding to no pain, and 10 corresponding to the worst pain imaginable)

  Day 28

• Patient-reported tolerability of ART procedure

  Tolerability will be assessed on an 10-point scale (range 1 to 10, with 1 corresponding to most tolerable, and 10 corresponding to least tolerable)

  End of study (Day 28)

• Physician-reported tolerability of ART procedure

  Tolerability will be assessed on an 10-point scale (range 1 to 10, with 1 corresponding to most tolerable, and 10 corresponding to least tolerable)

  End of study (Day 28)

• Percent change in size of wound area as a measure of time to healing at Day 7

  Day 7

• Percent change in size of wound area as a measure of time to healing at Day 14

  Day 14

• Percent change in size of wound area as a measure of time to healing at Day 21

  Day 21

• Percent change in size of wound area as a measure of time to healing at Day 28

  Day 28

• Time to full epithelialization as a measure of quality of healing

  Epithelialization is defined as growth of epithelium over the wound surface

  Baseline to Day 28

Study Arms (1)

Skin Wound Patients

EXPERIMENTAL

Patients will receive ART for wound healing and will be followed for 28 days to determine success of the procedure.

Device: Autologous Regenerative Technology (ART)

Interventions

Autologous Regenerative Technology (ART) DEVICE

ART device with single-needle, fluid-assisted skin tissue harvesting technology.

Skin Wound Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any age ranging 18-90, any gender or ethnic background is a candidate.
• Subjects with chronic wounds that have been present for at least 4 weeks

You may not qualify if:

• Pregnant women.
• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Advanced Wound Care Center

Redwood City, California, 94063, United States

Location

Study Officials

• Geoffrey Gurtner, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 11, 2017
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)