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Silica-Based Wound Treatment (Curi01) Plus Standard Care Versus Standard Care Alone for Chronic Diabetic Foot Wounds (CURE1-DFU)

2026年11月8日 更新者：Cutempa Medical AG

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

280

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 德国
      • Bad Mergentheim、德国、97980
        • 招聘中
        • Diabetes Zentrum Bad Mergentheim
        • 接触：
          • Maria Roxana Olareanu, MD
      • Berlin、德国、13187
        • 招聘中
        • Studienzentrum Dr. Braun GmbH
      • Bremerhaven、德国、27574
        • 尚未招聘
        • Klinikum Bremerhaven Reinkenheide gGmbH
      • Chemnitz、德国、09116
        • 招聘中
        • Klinikum Chemnitz gGmbH
      • Duisburg、德国、47051
        • 招聘中
        • DZDM - Diabetes Zentrum Duisburg Mitte
      • Giessen、德国、35392
        • 招聘中
        • Universitätsklinikum Gießen und Marburg, Standort Gießen
      • Gladbeck、德国、45968
        • 招聘中
        • Hausarztzentrum Butendorf
      • Hanover、德国、30459
        • 招聘中
        • KRH Klinikum Siloah, Diabetologisches Fuß- und Wundzentrum
      • Jena、德国、07747
        • 尚未招聘
        • Universitätsklinikum Jena
      • Kiel、德国、24114
        • 招聘中
        • Diabetespraxis Kiel
      • München、德国、80336
        • 招聘中
        • LMU Klinikum, Sektion Angiologie
      • Wallerfing、德国、94574
        • 招聘中
        • Gemeinschaftspraxis Dres. Großkopf
      • Wuppertal、德国、42283
        • 招聘中
        • Helios Klinik Wuppertal, Zentrum für Dermatologie, Allergologie und Dermatochirurgie

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male, female or diverse patients aged ≥18 years at the time of signing the informed consent.

  • Willing and able to provide written informed consent.

  • 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.

  • 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.

  • 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).

  • 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)).

  • 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.

  • No amputation history driven by a diabetic cause in the target wound limb within the 12 months prior to Screening Visit (Visit 1).

  • Outpatients in an ambulatory setting.

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：Curi01

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).

其他：Standard of Care

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.
有源比较器：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.
其他：Standard of Care

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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants With Healed Target Wound at Day 84
大体时间：Day 84

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

次要结果测量

结果测量
措施说明
大体时间
Percentage Reduction in Wound Area From Baseline
大体时间：Baseline (Day 1), Day 28, Day 35, Day 42 and Day 84

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
Time to Complete Wound Granulation
大体时间：Baseline (Day 1) up to Day 84

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
Time to Complete Wound Closure
大体时间：Baseline (Day 1) up to Day 84

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
Time to 25% Reduction in Wound Area
大体时间：Baseline (Day 1) up to Day 84

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
Proportion of Participants With Healed Target Wound at Day 28 and Day 63
大体时间：Day 28 and Day 63

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
Change From Baseline in Diabetic Foot Ulcer Scale - Short Form (DFS-SF) Score
大体时间：Baseline (Day 1), Day 42 and Day 84

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

其他结果措施

结果测量
措施说明
大体时间
Incidence of Adverse Events (AEs) and Adverse Device Effects (ADEs)
大体时间：Baseline (Day 1) up to Day 84 (or Day 91/98 for participants with an additional follow-up visit)

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)
Patient's Global Impression of Improvement (CGI-I)
大体时间：Day 42 and Day 84

Patient-rated global improvement on a scale from 1 (very much better) to 7 (very much worse).
Day 42 and Day 84
Change From Baseline in PEDIS Classification
大体时间：Baseline (Day 1), Day 42 and Day 84

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
Number of Participants Requiring Antibiotic Treatment of the Target Wound
大体时间：Baseline (Day 1) up to Day 84

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cutempa Medical AG

调查人员

  • 首席研究员：Maria Roxana Olareanu, MD、Diabetes Zentrum Bad Mergentheim

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月20日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年11月8日

首先提交符合 QC 标准的

2026年11月8日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月8日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CURE1-DFU
  • CIV-25-12-055842 (注册表标识符：EUDAMED (CIV-ID))
  • DRKS00038553 (注册表标识符：DRKS (German Clinical Trials Register))
  • MDR-2025-015 (其他标识符：Ethics Committee of the State Medical Association of Baden-Württemberg - Reference Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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