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Chronic WoundsNCT03368534

Autologous Regenerative Technology (ART) For Wound Healing

A study testing Autologous Regenerative Technology (ART) in people with Chronic Wounds, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Wounds
What is being tested?
Autologous Regenerative Technology (ART)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Dec 2018to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford Advanced Wound Care Center

    Redwood City, California, 94063

Other trials in United States

About this study

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.

Read the detailed description

Skin wounds sometimes are difficult to heal by primary closure and often require tissue substitution by autologous grafting requiring harvesting of donor skin. The latter may cause morbidities such as risk of infection, discoloration, pain, and scarring of both donor and recipient areas. Full-thickness stin grafts (FTSG) are created when the entire dermis and epidermis are harvested, These grafts are typically used for acute full-thickness wounds where the wound can sustain and nourish the graft and improved cosmesis is important. Split-thickness skin grafting (STSG) has been used to close large skin wounds, and it involves the harvesting of the epidermis and upper dermis from a donor site. It is generally the preferred grafting method for restoring the structural integrity of chronic wounds, as the wound bed may not have the ability to support a FTSG. Nevertheless, because deep dermal structures such as sweat glands and hair follicles are not harvested, the STSG is functionally abnormal. Before the grafting process takes place, STSGs are commonly meshed and enlarged, increasing the coverage area and allowing fluid drainage. However, the meshing process produces a "fish-net" appearance of the grafted skin. Other limitations include healing of the donor site, which often is delayed and leaves unappealing pigmentary changes and, at times, scar formation.

Currently, engineered "off the shelf" grafts such as cadaveric skin, xenografts, and artificial skin substitutes are being used in the management of chronic, difficult to heal wounds. Skin substitutes work by providing cells, growth factors, and other key elements that promote healing while preventing extracellular matrix degradation. However, these only offer transient wound coverage, and require secondary healing of the wound itself. Thus, autologous skin grafting continues to be necessary. Scar formation at the donor and grafted site remain most troublesome morbidities in autologous skin grafting. Scar tissue is stiff, dysfunctional, often painful, and tends to contract over time, producing skin irregularities.

In contrast, skin remodeling is a process that substitutes missing tissue while preserving tissue architecture. While scarring is triggered by large-scale tissue damage, remodeling is stimulated by microscopic tissue damage. This principle became clear when fractional photothermolysis (FP) was developed that is currently used for photoaged skin treatment and wound scars. In FP, laser microbeams are used to produce microscopic thermal injury per cm2 of skin surface, which causes very thin columns of tissue damage or ablation. It has been found that columns less than 500 µm in diameter heal promptly without scarring. FP involves full-thickness (i.e. complete epidermis and dermis) tissue injury in which the epidermis closes within 1 day, and the dermal damage is fixed in around 2 weeks, followed by tissue remodeling without scarring.

Because the experience with FP showed that millions of small, full-thickness columns of skin tissue can be removed without scarring, it was hypothesized that full-thickness microscopic skin tissue columns (MSTCs) could be harvested from healthy skin with insignificant donor site-morbidity and that these MSTCs could function as a graft to accelerate wound healing.

To explore this, a prototype device was developed that can harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology. The harvested MSTCs can subsequently be placed directly onto a wound to aid in healing.

With conventional full thickness grafts and split thickness grafts, the donor area requires sometimes a period of immobility, requiring attentive wound care and pain management. The ART may provide a more effective method of harvesting skin with minimal or no pain, healing rapidly with little scarring. This can take place in an outpatient setting, with the use of only local anesthesia.

Conditions
Chronic Wounds
Being tested
Autologous Regenerative Technology (ART)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Regenerative Technology (ART)Device

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

Study groups in NCT03368534
Study groupRoleWhat they receive
Skin Wound PatientsExperimentalPatients will receive ART for wound healing and will be followed for 28 days to determine success of the procedure.
Receives: Device: Autologous Regenerative Technology (ART)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 7

  2. 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)

    Measured: Day 14

  3. 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)

    Measured: Day 21

  4. 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)

    Measured: Day 28

  5. 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)

    Measured: End of study (Day 28)

  6. 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)

    Measured: End of study (Day 28)

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

    Measured: Day 7

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

    Measured: Day 14

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

    Measured: Day 21

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

    Measured: Day 28

  11. Time to full epithelialization as a measure of quality of healing

    Epithelialization is defined as growth of epithelium over the wound surface

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Why it stopped: Device needs modifications

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03368534
Sponsor's protocol ID
42628
Status last verified
May 2022
First submitted
27 Nov 2017
Last updated
4 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No current plan to share data

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Regenerative Technology (ART) in people with Chronic Wounds, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported pain at skin donor site at Day 7 (time frame: Day 7). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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