Silica-Based Wound Treatment (Curi01) Plus Standard Care Versus Standard Care Alone for Chronic Diabetic Foot Wounds (CURE1-DFU)
A Randomized, Controlled Clinical Study to Investigate the Efficacy and Safety of a Physically Active SiO2-Aerosil Mixture (Curi01) in Addition to Standard of Care Versus Standard of Care Only in the Treatment of Chronic, Exudating Foot Wounds in Diabetic Patients (DFU)
The goal of this clinical trial is to learn if Curi01, a powder made of silica (silicon dioxide) particles, helps chronic, oozing diabetic foot ulcers heal when it is added to standard wound care. Curi01 is sprinkled directly onto the wound, where it soaks up wound fluid and forms a gel that is washed off at the next dressing change.
The main questions it aims to answer are:
Do more wounds heal completely within 12 weeks when Curi01 is added to standard wound care, compared with standard wound care alone? A wound counts as healed when it is fully closed and still closed 14 days later.
Is Curi01 safe and well tolerated?
Researchers will compare Curi01 plus standard wound care to standard wound care alone. Standard wound care includes removing dead tissue, cleaning the wound, non-medicated dressings and pressure relief for the foot if applicable.
Participants will:
Be adults with type 1 or type 2 diabetes who have an oozing foot ulcer (2 to 10 cm²) that has been present for at least 6 weeks and has not improved enough with standard wound care First receive standard wound care for 2 weeks to check whether the wound improves on its own Then be assigned by chance to one of the two groups; 2 out of 3 participants will receive Curi01 Visit the study site up to 18 times over about 14 weeks; in the Curi01 group, the powder is applied at each visit until the wound is dry Have their wound photographed and measured with a wound imaging app at each visit Answer questionnaires about their quality of life and how they feel their condition has changed Be asked about any side effects or health problems
About 280 participants will take part at around 20 study sites in Germany. Participants and doctors will know which treatment is being given.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Noëlle Moser- van der Geest, MD
- Número de telefone: +41 79 710 35 30
- E-mail: n.moser@cutempamedical.com
Locais de estudo
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Bad Mergentheim, Alemanha, 97980
- Recrutamento
- Diabetes Zentrum Bad Mergentheim
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Contato:
- Maria Roxana Olareanu, MD
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Berlin, Alemanha, 13187
- Recrutamento
- Studienzentrum Dr. Braun GmbH
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Bremerhaven, Alemanha, 27574
- Ainda não está recrutando
- Klinikum Bremerhaven Reinkenheide gGmbH
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Chemnitz, Alemanha, 09116
- Recrutamento
- Klinikum Chemnitz gGmbH
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Duisburg, Alemanha, 47051
- Recrutamento
- DZDM - Diabetes Zentrum Duisburg Mitte
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Giessen, Alemanha, 35392
- Recrutamento
- Universitätsklinikum Gießen und Marburg, Standort Gießen
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Gladbeck, Alemanha, 45968
- Recrutamento
- Hausarztzentrum Butendorf
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Hanover, Alemanha, 30459
- Recrutamento
- KRH Klinikum Siloah, Diabetologisches Fuß- und Wundzentrum
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Jena, Alemanha, 07747
- Ainda não está recrutando
- Universitätsklinikum Jena
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Kiel, Alemanha, 24114
- Recrutamento
- Diabetespraxis Kiel
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München, Alemanha, 80336
- Recrutamento
- LMU Klinikum, Sektion Angiologie
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Wallerfing, Alemanha, 94574
- Recrutamento
- Gemeinschaftspraxis Dres. Großkopf
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Wuppertal, Alemanha, 42283
- Recrutamento
- Helios Klinik Wuppertal, Zentrum für Dermatologie, Allergologie und Dermatochirurgie
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Male, female or diverse patients aged ≥18 years at the time of signing the informed consent.
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Willing and able to provide written informed consent.
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Signed declaration of consent and signed data protection declaration after having been informed about the nature, relevance and the scope of the investigation and about the expected desired and undesired effects of the medical device.
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Patients with stable diabetes mellitus type 1 or 2 (HbA1c level <12%) receiving antidiabetic treatment, if medically indicated. Historic values up to 6 months before Visit 1 may be used.
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Chronic, exudating diabetic foot ulcer (DFU): Armstrong staging A or B, Wagner scale grades 1-2 and a wound surface between 2-10 cm². The foot is defined as the anatomical region distal to a line 3 cm proximal to the upper limit of the ankle joint; the target wound must be located within this region. "Chronic" is defined as present for at least 6 weeks prior to Screening Visit (Visit 1).
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Previous treatment of DFU with standard of care (SoC) for at least 2 weeks before Baseline Visit (Visit 2), without relevant improvement (i.e., <30% wound area reduction between Screening Visit (Visit 1) and Baseline Visit (Visit 2)).
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Patients without wound infection or with mild wound infection ("mild" is defined as no antibiotic therapy is needed for the treatment of the infected wound). In the case of wound infection, antibiotic treatment must be stopped at least 48 hours prior to Visit 1.
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No amputation history driven by a diabetic cause in the target wound limb within the 12 months prior to Screening Visit (Visit 1).
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Outpatients in an ambulatory setting.
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The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of Screening Visit (Visit 1) are acceptable (may also be the status after revascularization):
- Ankle-Brachial-Index (ABI) between 0.6 and 1.4
- Toe-Brachial-Index (TBI) ≥ 0.7
- Pulse Volume Recording (PVR): biphasic
- Imaging procedure that rules out critical ischemia (duplex sonography, computed tomography or magnetic resonance angiography)
Exclusion Criteria:
- Granulating wounds in regeneration phase.
- Wounds with a necrotic eschar (dry or wet) which cannot be debrided without surgery (i.e., without surgical debridement which would require an operating room and anesthesia).
- Wounds with sinuses and strong necrosis.
- Autolytic debridement as pre-treatment within one month prior to enrollment.
- Immunosuppressed patients (uncontrolled immunological disease, active systemic infection, and/or receiving immunosuppressive therapy). Corticosteroids with a daily dose of ≤ 5 mg prednisone (or equivalent) are acceptable.
- Previous treatment with a platelet derived growth factor (PDGF).
- Participation in another clinical trial within the last 4 weeks (i.e., 28 days) or previous participation in this clinical trial.
- Active cancer disease, osteomyelitis, known coagulation disorders (i.e., clinically relevant primary procoagulant coagulation disorders that require specific treatment, e.g., thrombophilia; secondary prophylactic anticoagulation is not excluded), known severe renal complications (dialysis, glomerular filtration rate [GFR] below 30 mL/min), symptomatic congestive heart failure (ejection fraction <30%).
- Pregnant and/or breastfeeding women.
- Women of childbearing potential who do not use a highly effective method of contraception (i.e., Pearl Index ≤ 1).
- Patients with silica hypersensitivity or allergy.
- Any other condition/treatment that the investigator considers may compromise the patients' safety and/or the integrity of the data.
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Curi01 + Standard of Care
Curi01 silica microparticle powder applied topically to the target wound (layer of approx. 3-5 mm, covering the entire wound surface) at each study visit, followed by a sterile dressing, in addition to standard of care, for up to 12 weeks. Application may be stopped after Day 8 once the wound is dry and restarted if exudation resumes. |
Sterile, powder-based wound exudate adsorbing agent composed of two types of silicon dioxide particles. Applied topically to the target wound evenly and generously (layer of approx. 3-5 mm) until the wound surface is completely covered, then covered with a sterile dressing. Applied at each study visit for up to 12 weeks; may be stopped once the wound is dry and restarted if exudation resumes. Class IIb medical device, not CE-marked (investigational). Standard wound care as defined in the protocol: debridement (sharp/surgical or mechanical) as needed, wound cleansing with sterile saline or an approved antiseptic (polyhexanide, octenidine or chlorhexidine), non-active wound dressings without antimicrobial, pharmacologic or biological agents, offloading if applicable, and compression therapy if indicated. |
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Comparador Ativo: Standard of Care
Standard of care alone for up to 12 weeks: debridement as needed, wound cleansing with sterile saline or approved antiseptic, non-active wound dressings, offloading, and compression therapy if indicated. |
Standard wound care as defined in the protocol: debridement (sharp/surgical or mechanical) as needed, wound cleansing with sterile saline or an approved antiseptic (polyhexanide, octenidine or chlorhexidine), non-active wound dressings without antimicrobial, pharmacologic or biological agents, offloading if applicable, and compression therapy if indicated. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Participants With Healed Target Wound at Day 84
Prazo: Day 84
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Healing is defined as complete wound closure (confirmed by the investigator for the first time) without drainage, with closure confirmed again 14 days later. Wound closure may only be confirmed by the investigator after the wound imaging software (Pixacare WoundTrack-II) has registered a wound area below 1 cm². Healing confirmed at an earlier visit is carried forward to Day 84. The difference in proportions between Curi01 + standard of care and standard of care alone is assessed for superiority. |
Day 84
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage Reduction in Wound Area From Baseline
Prazo: Baseline (Day 1), Day 28, Day 35, Day 42 and Day 84
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Percentage reduction in target wound area (cm²) from Baseline (Visit 2, Day 1), measured with the wound imaging software Pixacare WoundTrack-II from a calibrated photograph. Compared between Curi01 + standard of care and standard of care alone. |
Baseline (Day 1), Day 28, Day 35, Day 42 and Day 84
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|
Time to Complete Wound Granulation
Prazo: Baseline (Day 1) up to Day 84
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Time from Baseline (Day 1) to complete granulation of the target wound, with granulation tissue (%) measured by the Pixacare WoundTrack-II tissue analysis module. |
Baseline (Day 1) up to Day 84
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Time to Complete Wound Closure
Prazo: Baseline (Day 1) up to Day 84
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Time from Baseline (Day 1) to complete closure of the target wound, confirmed by the investigator after the wound imaging software (Pixacare WoundTrack-II) has registered a wound area below 1 cm². |
Baseline (Day 1) up to Day 84
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Time to 25% Reduction in Wound Area
Prazo: Baseline (Day 1) up to Day 84
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Time from Baseline (Day 1) until the target wound area (cm²), measured with Pixacare WoundTrack-II, has decreased by at least 25% compared with Baseline. |
Baseline (Day 1) up to Day 84
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Proportion of Participants With Healed Target Wound at Day 28 and Day 63
Prazo: Day 28 and Day 63
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Healing is defined as complete wound closure (confirmed by the investigator for the first time) without drainage, with closure confirmed again 14 days later. Healing confirmed at an earlier visit is carried forward to later visits. |
Day 28 and Day 63
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Change From Baseline in Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Score
Prazo: Baseline (Day 1), Day 42 and Day 84
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Disease-specific health-related quality of life assessed with the validated 29-item DFS-SF questionnaire. Change from Baseline (Day 1) is compared between treatment groups. |
Baseline (Day 1), Day 42 and Day 84
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Adverse Device Effects (ADEs)
Prazo: Baseline (Day 1) up to Day 84 (or Day 91/98 for participants with an additional follow-up visit)
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Number and percentage of participants with AEs and ADEs, including serious events, recorded from Baseline (Day 1) until the end of study visit. |
Baseline (Day 1) up to Day 84 (or Day 91/98 for participants with an additional follow-up visit)
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Patient's Global Impression of Improvement (CGI-I)
Prazo: Day 42 and Day 84
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Patient-rated global improvement on a scale from 1 (very much better) to 7 (very much worse). |
Day 42 and Day 84
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Change From Baseline in PEDIS Classification
Prazo: Baseline (Day 1), Day 42 and Day 84
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Diabetic foot ulcer severity assessed by the investigator using the PEDIS classification (Perfusion, Extent, Depth, Infection, Sensation). |
Baseline (Day 1), Day 42 and Day 84
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Number of Participants Requiring Antibiotic Treatment of the Target Wound
Prazo: Baseline (Day 1) up to Day 84
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Number of participants in each group who receive local or systemic antibiotic treatment for the target wound during the study. |
Baseline (Day 1) up to Day 84
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Roxana Olareanu, MD, Diabetes Zentrum Bad Mergentheim
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Diabetes Mellitus
- Angiopatias Diabéticas
- Complicações do Diabetes
- Doenças de pele
- Úlcera de pele
- Úlcera de perna
- Neuropatias diabéticas
- Úlcera do pé
- Doenças da Pele e do Tecido Conjuntivo
- Pé diabético
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- CURE1-DFU
- CIV-25-12-055842 (Identificador de registro: EUDAMED (CIV-ID))
- DRKS00038553 (Identificador de registro: DRKS (German Clinical Trials Register))
- MDR-2025-015 (Outro identificador: Ethics Committee of the State Medical Association of Baden-Württemberg - Reference Number)
Plano para dados de participantes individuais (IPD)
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