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Studio multicentrico, prospettico, randomizzato e controllato per la valutazione di SkinTE® nel trattamento delle ulcere del piede diabetico Wagner 1 (COVER DFU II)

2 novembre 2026 aggiornato da: PolarityTE

Studio multicentrico, prospettico, randomizzato e controllato sulla valutazione di SkinTE® nel trattamento delle ulcere del piede diabetico Wagner 1. Chiusura ottenuta con rigenerazione epiteliale vascolarizzata per DFU con 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SkinTE

SkinTE plus standard care
Biologico: 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.

Altri nomi:
  • Costrutto cutaneo autologo eterogeneo
Altro: Control

Standard care alone
Altro: 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
Altri nomi:
  • Standard di sicurezza

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of index ulcers closed
Lasso di tempo: 12 weeks

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tempo di chiusura
Lasso di tempo: 24 settimane
24 settimane
Numero totale di visite cliniche di persona per la cura delle ferite e/o giorni di ricovero correlati all'ulcera indice.
Lasso di tempo: 24 settimane
24 settimane
Giorni totali di utilizzo del CAM Boot relativi all'ulcera indice
Lasso di tempo: 24 settimane
24 settimane
Percent area reduction (PAR)
Lasso di tempo: Assessed at 4, 8, and 12 weeks

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

PolarityTE

Collaboratori

Professional Education and Research Institute

Investigatori

  • Direttore dello studio: Nikolai Sopko, MD, PhD, PolarityBio

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 febbraio 2024

Completamento primario (Effettivo)

30 gennaio 2026

Completamento dello studio (Effettivo)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

15 novembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

15 novembre 2023

Primo Inserito (Effettivo)

18 novembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COVER DFUs II

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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