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Ensayo controlado aleatorio, prospectivo y multicéntrico que evalúa SkinTE® en el tratamiento de las úlceras del pie diabético Wagner 1 (COVER DFUs II)

2 de noviembre de 2026 actualizado por: PolarityTE

Ensayo controlado aleatorio, prospectivo y multicéntrico que evalúa SkinTE® en el tratamiento de las úlceras del pie diabético de Wagner 1. Cierre obtenido con regeneración epitelial vascularizada para UPD 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

120

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SkinTE

SkinTE plus standard care
Biológico: 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.

Otros nombres:
  • Construcción de piel heterogénea autóloga
Otro: Control

Standard care alone
Otro: 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
Otros nombres:
  • Estándar de cuidado

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of index ulcers closed
Periodo de tiempo: 12 weeks

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tiempo de cierre
Periodo de tiempo: 24 semanas
24 semanas
Número total de visitas clínicas para el cuidado de heridas en persona y/o días de hospitalización relacionados con la úlcera índice.
Periodo de tiempo: 24 semanas
24 semanas
Días totales de uso de CAM Boot relacionados con la úlcera índice
Periodo de tiempo: 24 semanas
24 semanas
Percent area reduction (PAR)
Periodo de tiempo: Assessed at 4, 8, and 12 weeks

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

PolarityTE

Colaboradores

Professional Education and Research Institute

Investigadores

  • Director de estudio: Nikolai Sopko, MD, PhD, PolarityBio

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de febrero de 2024

Finalización primaria (Actual)

30 de enero de 2026

Finalización del estudio (Actual)

30 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de noviembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

15 de noviembre de 2023

Publicado por primera vez (Actual)

18 de noviembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • COVER DFUs II

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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