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.
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
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 group | Role | What they receive |
|---|---|---|
| Skin Wound Patients | Experimental | Patients 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.
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
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
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
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
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)
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)
Percent change in size of wound area as a measure of time to healing at Day 7
Measured: Day 7
Percent change in size of wound area as a measure of time to healing at Day 14
Measured: Day 14
Percent change in size of wound area as a measure of time to healing at Day 21
Measured: Day 21
Percent change in size of wound area as a measure of time to healing at Day 28
Measured: Day 28
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.
- First posted11 Dec 2017
- Study start1 Dec 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: Device needs modifications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey C. Gurtner, Stanford University
- Investigators
- Geoffrey Gurtner, MD, Principal investigator, Stanford University
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Regenerative Technology (ART) For Wound Healing
- ClinicalTrials.gov ID
- NCT03368534
- Acronym / sponsor ID
- 42628
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device needs modifications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Wound Patients | Experimental | Device: Autologous Regenerative Technology (ART)Patients will receive ART for wound healing and will be followed for 28 days to determine success of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Regenerative Technology (ART)ART device with single-needle, fluid-assisted skin tissue harvesting technology. | Device | Skin Wound Patients |
Primary outcome
Patient-reported pain at skin donor site at Day 7
Time frame: 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)
Patient-reported pain at skin donor site at Day 14
Time frame: 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)
Patient-reported pain at skin donor site at Day 21
Time frame: 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)
Patient-reported pain at skin donor site at Day 28
Time frame: 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)
Patient-reported tolerability of ART procedure
Time frame: End of study (Day 28)
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)
Physician-reported tolerability of ART procedure
Time frame: End of study (Day 28)
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)
Percent change in size of wound area as a measure of time to healing at Day 7
Time frame: Day 7
Percent change in size of wound area as a measure of time to healing at Day 14
Time frame: Day 14
Percent change in size of wound area as a measure of time to healing at Day 21
Time frame: Day 21
Percent change in size of wound area as a measure of time to healing at Day 28
Time frame: Day 28
Time to full epithelialization as a measure of quality of healing
Time frame: Baseline to Day 28
Epithelialization is defined as growth of epithelium over the wound surface
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No. No current plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Gurtner, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
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.