Venous Leg UlcerNCT03881267
SkinTE® in the Treatment of Venous Leg Wounds
A study testing Human Autologous Homologous Skin Construct, Additional Outer Dressing Application and Fibracol Wound Dressing in people with Venous Leg Ulcer and Venous Stasis, run by PolarityTE at 2 sites in United States.
Trial summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- What is being tested?
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Application and Fibracol Wound Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2019to 23 Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Presence of a VLU on the leg, below the knee but above the aspect of the medial malleolus, extending at least through the dermis or subcutaneous tissue but not involving tendon, muscle, or bone.
- The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit, as of the date subject consents for study.
- Index ulcer is a minimum of 2.0 cm2 and a maximum of 20 cm2 at first screening visit (SV1) and first treatment visit (TV1).
- Adequate circulation to the affected extremity as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow within 3 months of SV1, using the affected study extremity.
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- The index ulcer has been treated with high compression for at least 14 days prior to randomization (30-40 mm Hg).
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
- Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures have been completed.
- The index ulcer has a clean granular base, is free of necrotic debris, and appears to be healthy vascularized tissue at time of placement of treatment product.
- Subject is deemed healthy and stable for treatment based per PI discretion.
Who cannot join
- Subjects with a BMI ≥45
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
- History of radiation at the ulcer site (regardless of time since last radiation treatment).
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- Index ulcer has been previously treated or will need to be treated with any prohibited therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids > 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
- Study ulcer requiring negative pressure wound therapy during the course of the trial.
- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
- Subject is pregnant or breast-feeding.
- Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization.
- Subjects with end stage renal disease as evidenced by a creatinine greater than 3.0mg/dl within 120 days of randomization.
- Target wound has presence of local active soft tissue infection involving the treatment site.
- Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
- In the opinion of the Investigator, evidence of unstable human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
- Vascular surgery; arterial or venous to the affected extremity within 30 days of screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Martinsville Research Institute
Martinsville, Virginia, 23116
Professional Education and Research Institute
Roanoke, Virginia, 24016
About this study
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Venous Leg Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds
Read the detailed description
This study is a prospective, multi-center, Randomized Controlled Trial (RCT) designed to collect patient outcome data on a commercially available human autologous homologous skin construct (SkinTE) with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds (VLU). The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.
There are two arms in the study:
Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and the experimental wound care covering with human autologous,homologous skin construct (SkinTE) followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).
Arm 2: The Standard of Care Arm. The SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
- Conditions
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- Being tested
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Application, Fibracol Wound Dressing
- Keywords
- VLU, Ulcer, SkinTE
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Autologous Homologous Skin ConstructOther
Also called SkinTE
Application of a autologous human derived skin polar units
Additional Outer Dressing ApplicationOther
Also called •Outer protective and compressive dressing
Application of Moisture retentive dressing, and a multi-layer compression dressing
Fibracol Wound DressingOther
Also called Collegen Alginate
Application of Collagen Alginate Dressing
| Study group | Role | What they receive |
|---|---|---|
| Human Autologous Homologous Skin Construct (SkinTE) | Experimental | SkinTE, is an autologous, homologous, FDA-registered, cutaneous human cellular and tissue-based product (HCT/P) that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a venous leg wound in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing and compression Receives: Other: Human Autologous Homologous Skin Construct; Other: Additional Outer Dressing Application |
| Fibracol Wound Dressing | Active comparator | A commercially available wound dressing to be used per manufacturer's instructions for use on venous leg wounds in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing and compression Receives: Other: Additional Outer Dressing Application; Other: Fibracol Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of index ulcers healed at 12 weeks
examine percent of ulcers healed at week twelve
Measured: 12 weeks
Secondary outcomes (6)
Percentage area reduction at 4 weeks
examine percent of wound reduction at 4 weeks
Measured: 4 weeks
Percentage area reduction at 6 weeks
examine percent of wound reduction at 6 weeks
Measured: 6 weeks
Percentage area reduction at 8 weeks
examine percent of wound reduction at 8 weeks
Measured: 8 weeks
Percentage are reduction at 12 weeks
examine percent of wound reduction at 12 weeks
Measured: 12 weeks
Improvement in quality of life using Wound Quality of Life Score
The Wound-QoL, or wound quality of life questionnaire, measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days. This questionnaire will be given to clinical trial participants at each visit, with the scale scores recorded. Each question is scored. Answers to each item are coded with numbers (0='not at all' to 4='very much'). As noted above the score will be reported with a minimam score of "0" and a maximum score of 68
Measured: 12 weeks
Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain
The FACES pain scale will be administered to the clinical trial participants at each visit. The trial participant will select their pain level with a series of faces that correspond to a number between 0 which implies no pain , up to 10 which implies the most severe pain. The scores will be recorded for each clinical trial participant on each visit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start29 Mar 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Human Homologous Autologous Skin Construct (SkinTE™) in the Treatment of Venous Leg Ulcers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolarityTE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- David Armstrong, DPM, MD, PhD, Principal investigator, USC/ Salsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881267
- Sponsor's protocol ID
- STE-VLU-01
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE® in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03881267
- Acronym / sponsor ID
- STE-VLU-01
- Conditions
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- Keywords
- VLU, Ulcer, SkinTE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PolarityTEIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 19 Mar 2019 (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.
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds
Detailed description
This study is a prospective, multi-center, Randomized Controlled Trial (RCT) designed to collect patient outcome data on a commercially available human autologous homologous skin construct (SkinTE) with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds (VLU). The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.
There are two arms in the study:
Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and the experimental wound care covering with human autologous,homologous skin construct (SkinTE) followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).
Arm 2: The Standard of Care Arm. The SOC therapy in this study is appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Human Homologous Autologous Skin Construct (SkinTE™) in the Treatment of Venous Leg Ulcers
| Arm | Type | Receives |
|---|---|---|
| Human Autologous Homologous Skin Construct (SkinTE) | Experimental | Other: Human Autologous Homologous Skin Construct, Other: Additional Outer Dressing ApplicationSkinTE, is an autologous, homologous, FDA-registered, cutaneous human cellular and tissue-based product (HCT/P) that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a venous leg wound in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing and compression |
| Fibracol Wound Dressing | Active comparator | Other: Additional Outer Dressing Application, Other: Fibracol Wound DressingA commercially available wound dressing to be used per manufacturer's instructions for use on venous leg wounds in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing and compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years old.
- Presence of a VLU on the leg, below the knee but above the aspect of the medial malleolus, extending at least through the dermis or subcutaneous tissue but not involving tendon, muscle, or bone.
- The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit, as of the date subject consents for study.
- Index ulcer is a minimum of 2.0 cm2 and a maximum of 20 cm2 at first screening visit (SV1) and first treatment visit (TV1).
Key exclusion criteria (18 listed)
- Subjects with a BMI ≥45
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
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 |
|---|---|---|
| Human Autologous Homologous Skin ConstructAlso: SkinTEApplication of a autologous human derived skin polar units | Other | Human Autologous Homologous Skin Construct (SkinTE) |
| Additional Outer Dressing ApplicationAlso: •Outer protective and compressive dressingApplication of Moisture retentive dressing, and a multi-layer compression dressing | Other | Fibracol Wound Dressing, Human Autologous Homologous Skin Construct (SkinTE) |
| Fibracol Wound DressingAlso: Collegen AlginateApplication of Collagen Alginate Dressing | Other | Fibracol Wound Dressing |
Primary outcome
Percentage of index ulcers healed at 12 weeks
Time frame: 12 weeks
examine percent of ulcers healed at week twelve
6 secondary outcomes
Percentage area reduction at 4 weeks
Time frame: 4 weeks
Percentage area reduction at 6 weeks
Time frame: 6 weeks
Percentage area reduction at 8 weeks
Time frame: 8 weeks
Percentage are reduction at 12 weeks
Time frame: 12 weeks
Improvement in quality of life using Wound Quality of Life Score
Time frame: 12 weeks
Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
David Armstrong, DPM, MD, PhD principal investigator
USC/ Salsa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Autologous Homologous Skin Construct, Additional Outer Dressing Application and Fibracol Wound Dressing in people with Venous Leg Ulcer and Venous Stasis, run by PolarityTE at 2 sites 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 12 inclusion and 18 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: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of index ulcers healed at 12 weeks (time frame: 12 weeks). 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 Apr 2022.