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Multisenter, prospektiv, randomisert kontrollert studie som evaluerer SkinTE® i behandling av Wagner 1 diabetiske fotsår (COVER DFUs II)

2. november 2026 oppdatert av: PolarityTE

Multisenter, prospektiv, randomisert kontrollert studie som evaluerer SkinTE® i behandling av Wagner 1 diabetiske fotsår. Lukking oppnådd med vaskularisert epitelregenerering for DFUer med SkinTE® II (COVER DFUS II)

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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, silicone dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 1 diabetic foot ulcers (DFUs) ranging in size from 1 to 15 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 (closure confirmed by 3 blinded adjudicators) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Mesa, Arizona, Forente stater, 85202
        • Titan Clinical Research
    • California
      • Castro Valley, California, Forente stater, 94546
        • Center for Clinical Research
      • Fresno, California, Forente stater, 93710
        • Limb Preservation Platform, Inc.
      • Los Angeles, California, Forente stater, 90010
        • Angel City Research
      • Los Angeles, California, Forente stater, 92704
        • Clemente Clinical Research Inc.
      • San Francisco, California, Forente stater, 94115
        • Center for Clinical Research
      • Santa Ana, California, Forente stater, 92704
        • Clemente Clinical Research Inc.
      • Vista, California, Forente stater, 92081
        • ILD Research
    • Florida
      • Hialeah, Florida, Forente stater, 33010
        • Las Mercedes Medical Research, Inc.
      • Miami, Florida, Forente stater, 33156
        • Doctors Research Network
      • Pinellas Park, Florida, Forente stater, 33782
        • DMI Research
      • Tamarac, Florida, Forente stater, 33321
        • Barry University Clinical Research
    • Maryland
      • Hagerstown, Maryland, Forente stater, 21742
        • FASMA - Hagerstown
    • Nevada
      • Henderson, Nevada, Forente stater, 89014
        • Viable Research Management
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • Northwell Health, Inc.
      • New York, New York, Forente stater, 10019
        • Mount Sinai West Hospital
    • Ohio
      • Boardman, Ohio, Forente stater, 44512
        • LEIRT (Lower Extremity Institute for Research and Therapy)
      • Circleville, Ohio, Forente stater, 43123
        • Cutting Edge Research LLC
      • East Liverpool, Ohio, Forente stater, 43920
        • LEIRT (Lower Extremity Institute for Research and Therapy)
      • Grove City, Ohio, Forente stater, 43123
        • Cutting Edge Research LLC
    • Texas
      • Houston, Texas, Forente stater, 77055
        • Perfizien Clinical Research LLC.
      • Plano, Texas, Forente stater, 75093
        • Baylor Scott & White Health
    • Virginia
      • Salem, Virginia, Forente stater, 24153
        • Foot and Ankle Specialists of the Mid-Atlantic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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 1 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 1 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 15 cm2 at first screening visit (SV1) and first randomization visit (RV1).
  • 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, 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 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 study visits and the follow-up regimen.
  • Females of childbearing potential must agree to use effective methods of c 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.

Exclusion Criteria:

  • 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 visit (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.]
  • 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 with an 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 screening (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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SkinTE

SkinTE plus standard care
Biologisk: SkinTE

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.

Andre navn:
  • Autolog heterogen hudkonstruksjon
Annen: Control

Standard care alone
Annen: Control

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

  • Debridement
  • Collagen dressing
  • Local offloading
  • Foam
  • Multi-layer compression dressing
  • Off-loading device such as a controlled ankle motion (CAM) boot
Andre navn:
  • Velferdstandard

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of index ulcers closed
Tidsramme: 12 weeks

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
På tide å stenge
Tidsramme: 24 uker
24 uker
Totalt antall personlige sårbehandlingsklinikker og/eller sykehusdager knyttet til indekssåret.
Tidsramme: 24 uker
24 uker
Totalt antall dager med CAM Boot-bruk relatert til indekssåret
Tidsramme: 24 uker
24 uker
Percent area reduction (PAR)
Tidsramme: Assessed at 4, 8, and 12 weeks

Change in wound area from the time of randomization
Assessed at 4, 8, and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

PolarityTE

Samarbeidspartnere

Professional Education and Research Institute

Etterforskere

  • Studieleder: Nikolai Sopko, MD, PhD, PolarityBio

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. februar 2024

Primær fullføring (Faktiske)

30. januar 2026

Studiet fullført (Faktiske)

30. april 2026

Datoer for studieregistrering

Først innsendt

15. november 2023

Først innsendt som oppfylte QC-kriteriene

15. november 2023

Først lagt ut (Faktiske)

18. november 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • COVER DFUs II

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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