Diabetic FootNCT03881254
SkinTE™ in the Treatment of Diabetic Foot Wounds
A study testing Human Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton and Offloading in people with Diabetic Foot and Diabetic Foot Ulcer, run by PolarityTE at 1 site 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 Diabetic Foot Wounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
- What is being tested?
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton and Offloading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 28 Jul 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 DFU, Wagner 1 (see Appendix B for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
- The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade 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 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
- Adequate circulation to the affected foot 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 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a Toe Brachial Index (TBI) of > 0.6 is acceptable.
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- The target ulcer has been offloaded for at least 14 days prior to randomization.
- 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.
- 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.
Who cannot join
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- 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).
- 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.
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- 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.
- Osteomyelitis or bone infection, cellulitis, or "active" Charcot's arthropathy of the affected foot near the site of the wound or on the same limb as the index ulcer as verified by X-ray, MRI, or bone biopsy within 30 days prior to randomization if any of the aforementioned conditions are expected. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision.)
- 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 serum creatinine of greater than 3.0 mg/dl within 120 days of randomization.
- Target wound has presence of local active soft tissue infection or Gangrene 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinsville Research Institute
Martinsville, Virginia, 23116
About this study
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTE™ in the Treatment of Wagner One Diabetic Foot 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 Diabetic Foot 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 Diabetic Foot Wounds (DFU) .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 thirteen 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 offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), 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 offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), 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
- Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
- Being tested
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Applicaiton, Offloading, Fibracol Wound Dressing
- Keywords
- DFU, Ulcer, Skin TE
- Medical subject headings
- Diabetic Foot, Foot 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 ApplicaitonOther
Also called Outer protective dressing
Application of Moisture retentive dressing, and a multi-layer compression dressing
OffloadingOther
Also called Pressure Relief
Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
Fibracol Wound DressingOther
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 diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing Receives: Other: Human Autologous Homologous Skin Construct; Other: Additional Outer Dressing Applicaiton; Other: Offloading |
| Fibracol Wound Dressing | Active comparator | A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing Receives: Other: Additional Outer Dressing Applicaiton; Other: Offloading; 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 (7)
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
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
Each clinical trial participant will be examined by the principal investigator with a Semmes Weinstein monofilament wire at 10 points on the study foot, this standardized exam will be scored out of a total of 10 at each visit and recorded
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 start2 Apr 2019
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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 Diabetic Foot Ulcers
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03881254
- Sponsor's protocol ID
- STE-DFU-01
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong DG, Orgill DP, Galiano R, Glat PM, Carter M, Zelen CM, Li WW. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020 Oct;17(5):1366-1375. doi: 10.1111/iwj.13404. Epub 2020 May 26.
PubMed 32453512
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. 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 Wagner One Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03881254
- Acronym / sponsor ID
- STE-DFU-01
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
- Keywords
- DFU, Ulcer, Skin TE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PolarityTEIndustry (pharma, biotech, devices)
- Collaborators
- Professional Education and Research Institute
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 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 Diabetic Foot 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 Diabetic Foot Wounds (DFU) .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 thirteen 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 offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), 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 offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), 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
- None (open label)
- 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 Diabetic Foot Ulcers
| Arm | Type | Receives |
|---|---|---|
| Human Autologous Homologous Skin Construct (SkinTE™) | Experimental | Other: Human Autologous Homologous Skin Construct, Other: Additional Outer Dressing Applicaiton, Other: OffloadingSkinTE™, 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 diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing |
| Fibracol Wound Dressing | Active comparator | Other: Additional Outer Dressing Applicaiton, Other: Offloading, Other: Fibracol Wound DressingA commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- At least 18 years old.
- Presence of a DFU, Wagner 1 (see Appendix B for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
- The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade 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 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
- Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
Key exclusion criteria (14 listed)
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- 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).
- 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).
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: SkinTE™Application of a autologous human derived skin polar units | Other | Human Autologous Homologous Skin Construct (SkinTE™) |
| Additional Outer Dressing ApplicaitonAlso: Outer protective dressingApplication of Moisture retentive dressing, and a multi-layer compression dressing | Other | Fibracol Wound Dressing, Human Autologous Homologous Skin Construct (SkinTE™) |
| OffloadingAlso: Pressure ReliefPatient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot | Other | Fibracol Wound Dressing, Human Autologous Homologous Skin Construct (SkinTE™) |
| Fibracol Wound DressingApplication 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
7 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
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test
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 26 Aug 2021.
- Background: PubMed 32453512Armstrong DG, Orgill DP, Galiano R, Glat PM, Carter M, Zelen CM, Li WW. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020 Oct;17(5):1366-1375. doi: 10.1111/iwj.13404. Epub 2020 May 26.
- 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
1 site 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 Applicaiton and Offloading in people with Diabetic Foot and Diabetic Foot Ulcer, run by PolarityTE 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 11 inclusion and 14 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 26 Aug 2021. 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 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?
On the ClinicalTrials.gov record for NCT03881254, which also lists 1 linked publication.
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 26 Aug 2021.