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Diabetic FootPhase 3COVER DFUsNCT05372809

Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs

A Phase 3 study testing SkinTE in people with Diabetic Foot, run by PolarityTE at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot
What is being tested?
SkinTE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
13 sitesUnited States
Study dates
28 Apr 2022to 21 Feb 2024
Phase
Phase 3
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

  • At least 18 years of age.
  • Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy.
  • Presence of a DFU Wagner 2 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. [NOTE: DFU must maintain Wagner 2 Grade for the duration of study run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).]
  • If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.]
  • Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥ 28 days) prior to the initial screening visit (SV1).
  • Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 10 cm2 at the first screening visit (SV1) and first randomization visit (RV1).
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  • 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) of ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75 at SV1, using the affected study extremity within 30 days of screening visit (SV1).
  • Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1.
  • The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through RV1/Randomization).
  • Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile).
  • Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
  • Females of childbearing potential must agree to use effective methods of contraception (birth control pills, barriers, or abstinence) (Screening through End of Study (EOS) and undergo pregnancy tests.
  • Properly obtained written informed consent.
  • Subject must have stable living environment in order to manage offloading and wound care management.
  • The index ulcer has a clean base, free of necrotic debris, and infection at time of placement of treatment product.

Who cannot join

  • Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
  • Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening (SV1).
  • Index ulcer in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
  • Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment).
  • Subjects with exposed internal fixation on the same limb as the index ulcer. [NOTE: External fixation is allowed if deemed stable by principal investigator.]
  • Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1). ). [NOTE: NPWT is allowed up to the day of screening (SV1), if in the opinion of the Principal Investigator NPWT may be discontinued.]
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  • Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol.
  • Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids > 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within 30 days prior to first screening visit (SV1), or who receive such medications during the run-in period, or who are anticipated to require such medications during the study.
  • Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
  • In the opinion of the investigator, the subject is non-compliant with offloading or index ulcer dressing during the run-in period.
  • Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
  • Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
  • Subject is pregnant or breast-feeding.
  • Presence of diabetes with poor metabolic control as documented as not having at least one HbA1c ≥12.0 within 30 days prior to randomization (RV1).
  • Subjects with end stage renal disease requiring treatment with dialysis and/or evident by an eGFR <30 mL/min/1.73m2 within 120 days of randomization (RV1). [NOTE: Subjects with two documented eGFR values within 120 days, the most recent value may be used if the eGFR ≥30 mL/min/1.73m2 and is, in the opinion of the principal investigator, stable and the subject will not require treatment with dialysis for the duration of study participation.]
  • Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit.
  • Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at first screening visit (SV1).
  • Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening (SV1).
  • Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation [NOTE: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial.]
  • Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • VA North Texas Health Care System

    Dallas, Texas, 75216

  • University of Texas Southwestern Wound Care Clinic

    Dallas, Texas, 75390

  • Limb Preservation Platform, INC

    Fresno, California, 93710

  • Royal Research, Corp

    Hollywood, Florida, 33021

  • LA Foot and Ankle Clinic

    Los Angeles, California, 900010

  • Futuro Clinical Trials, LLC

    McAllen, Texas, 78501

  • Mount Sinai West

    New York, New York, 10019

  • Northwell Health

    New York, New York, 11042

  • Gateway Clinical Trials

    O'Fallon, Illinois, 62269

  • Baylor Scott & White Research Institute - Plano

    Plano, Texas, 75204

  • Foot and Ankle Institute

    St. George, Utah, 84770

  • Barry University Clinical Research

    Tamarac, Florida, 33321

Other trials in United States

About this study

Official title: Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE®

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.

Read the detailed description

This study is a prospective, multi-center, randomized controlled trial (RCT) designed to assess the safety and efficacy of SkinTE with standard of care (SOC) dressings compared to SOC dressings alone (wound debridement, collagen-alginate dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 2 diabetic foot ulcers (DFUs) ranging in size from 1 to 10 cm2. After being informed about the study and potential risks, all patients giving written informed consent who meet eligibility criteria will undergo a 2-week screening period of SOC. Patients meeting eligibility criteria following the screening period will be randomized in a single-blind manner (blinded evaluator with closure confirmed by a blinded adjudicator) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure.

Conditions
Diabetic Foot
Being tested
SkinTE, Control
Keywords
diabetic foot ulcer, regenerative medicine, SkinTE, skin regeneration, chronic wounds, Wagner 2
Medical subject headings
Diabetic Foot

What participants receive

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

  • SkinTEBiological

    Also called Autologous Heterogeneous Skin Construct

    SkinTE is an Autologous Heterogeneous Skin Construct (AHSC), which is manufactured from a small piece of healthy full-thickness skin harvested from the patient at the time of randomization to the SkinTE arm. SkinTE is manufactured aseptically by PolarityTE following current Good Manufacturing Practice (cGMP). SkinTE is not cultured ex vivo; rather, it is returned to the provider expeditiously to maintain cellular viability. SkinTE includes various multicellular segments as a result of the manufacturing process. The different multicellular segments contain different types of skin cells, such as keratinocytes, dermal fibroblasts, dermal endothelial cells, and follicular cells, as well as extracellular matrix. The multicellular segments have a surface area-to-volume ratio for improved sustenance by imbibition prior to engraftment.

  • ControlOther

    Also called Standard of Care

    Standard care is defined in this protocol to include the following:

    • Debridement
    • Collagen-alginate primary wound dressing
    • Local offloading with felt pad for wounds on weight bearing surfaces
    • Foam
    • Multi-layer compression dressing
    • Off-loading device such as a full-length boot or total contact cast (if full-length boot cannot accommodate the patient) or surgical shoe for ulcers in non-weight bearing locations
Study groups in NCT05372809
Study groupRoleWhat they receive
SkinTEExperimentalSkinTE plus standard care
Receives: Biological: SkinTE
ControlOtherStandard care alone
Receives: Other: Control

What is being measured

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

  1. Incidence of index ulcers closed

    Wound closure is confirmed at two consecutive visits each two weeks apart

    Measured: 24 weeks

Secondary outcomes (5)

  1. Percent area reduction (PAR)

    Change in wound area from the time of randomization

    Measured: Assessed at 4, 8, 12, 16, 20, and 24 weeks

  2. Incidence of index ulcers closed

    Wound closure is confirmed at two consecutive visits each two weeks apart

    Measured: 12 weeks

  3. Time to closure

    Measured: up to 24 weeks

  4. Wound Quality of Life (w-QoL) Questionnaire

    Change in w-QoL from baseline

    Measured: 24 weeks

  5. Wound infection

    Incidence of new onset infection of index ulcer requiring treatment with antibiotics

    Measured: 24 weeks

Timeline

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

  1. First posted13 May 2022
  2. Study start28 Apr 2022
  3. Primary completion21 Feb 2024
  4. Study completion21 Feb 2024

Why it stopped: Study terminated due to slow enrollment and change in strategy.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
mult-center, randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372809
Sponsor's protocol ID
COVER DFUs
Acronym
COVER DFUs
Status last verified
Feb 2024
First submitted
6 May 2022
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SkinTE in people with Diabetic Foot, run by PolarityTE at 13 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 15 inclusion and 20 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: stopped early, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to slow enrollment and change in strategy.). Results are not available in the source record.

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?

Incidence of index ulcers closed (time frame: 24 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 NCT05372809.

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 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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