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Набор скоро начнётся NCT07745764

INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

— Наблюдательное Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: standard of care.
Кому может быть актуально
Состояния в реестре: Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates

Обзор

This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound biofilm/debridement material. Samples and routine clinical wound data will be used to test INJECTHEAL hydrogel components and other wound healing therapeutics, and identify molecular, biochemical, and microbiological biomarkers linked to wound healing.

Подробное описание

The Horizon Europe project INJECTHEAL platform is designed to provide a biomimetic matrix for tissue regeneration and to enable controlled delivery of antibacterial, anti-inflammatory, and pro-angiogenic components.

This is a monocentric, prospective, exploratory, non-interventional observational study. It involves the collection of biological material and health-related personal data from adults with chronic, non-healing deep cavity wounds who are treated as part of routine clinical care. Study data will be documented in doubly pseudonymized form.

Biological material will consist of routine clinical waste material. Wound exudate will be obtained from negative pressure wound therapy and biofilm/debridement material will be collected from medically indicated sharp or surgical debridement. Where feasible, longitudinal sampling will be performed during routine wound care visits, with approximately 3 to 5 visits expected per participant.

Components of the INJECTHEAL hydrogel system and other wound healing therapeutics will be evaluated for their capacity to mitigate or reverse inhibitory effects of chronic wound material on regenerative cellular functions.

Further analyses will include biochemical and molecular characterization of wound exudates, including total protein, proteases and protease activity, growth factors, cytokines, proteomic profiles, and metabolomic profiles. Biofilm samples will be analyzed using microbiological and molecular methods, including bacterial rRNA16S metagenomic sequencing and patient-specific 3D biofilm models to assess antibacterial effects of INJECTHEAL components.

Вмешательства

  • Другое standard of care
    Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.

Первичные конечные точки

  • Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts [Срок оценки: Four weeks]
  • Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples [Срок оценки: Four weeks]
Вторичные конечные точки (11)
  • Effects of Wound Material and Test Substances on Cell Migration [Срок оценки: Four weeks]
  • Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types [Срок оценки: Four weeks]
  • Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types [Срок оценки: Four weeks]
  • Protein content of wound exudate [Срок оценки: Four weeks]
  • Proteomics profile of wound exudate [Срок оценки: Four months]
  • Bacterial composition of wound biofilm by rRNA16S sequencing [Срок оценки: Four weeks]
  • Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data [Срок оценки: Four weeks]
  • Effects of Wound Material and Test Substances on Extracellular Matrix Formation [Срок оценки: 4 weeks]
  • Inflammatory Marker Response in Wound-Relevant Cell Types [Срок оценки: 4 weeks]
  • Metabolomics profile of wound exudate [Срок оценки: 4 months]
  • Protease acitivty [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Type I or type II diabetes with lower extremity deep cavity ulcers
  • Arterial leg ulcers with lower extremity deep cavity ulcers
  • Surgical deep cavity non-healing wounds
  • Wounds with delayed healing
  • Routine treatment with negative pressure wound therapy
  • Routine sharp or surgical debridement
  • Sufficient wound exudate available (min. of 2 ml per visit)
  • Patient is informed about the study and has given informed consent

Критерии исключения

  • Age ≤ 18 years
  • Multiple substance abuse (poly-toxicomania)
  • No signed declaration of consent or incapable of giving an informed written consent
  • Proven active infections with HIV, hepatitis C or HPV
  • Active pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Германия · 1 центр
  • Heinrich-Heine University, Duesseldorf — Düsseldorf

Публикации

  • Alavi A, Sibbald RG, Phillips TJ, Miller OF, Margolis DJ, Marston W, Woo K, Romanelli M, Kirsner RS. What's new: Management of venous leg ulcers: Approach to venous leg ulcers. J Am Acad Dermatol. 2016 Apr;74(4):627-40; quiz 641-2. doi: 10.1016/j.jaad.2014.10.048. PMID 26979354
  • Doerfler P, Schoefmann N, Cabral G, Bauer W, Berli MC, Binder B, Borst C, Botter S, French LE, Goerge T, Hafner J, Hartmann D, Hogh A, Hoetzenecker W, Holzer-Geissler JCJ, Kamolz LP, Kofler K, Luger T, Nischwitz SP, Popovits M, Rappersberger K, Restivo G, Schlager JG, Schmuth M, Stingl G, Stockinger T, Stroelin A, Stuetz A, Umlauft J, Weninger WP, Wolff-Winiski B. Development of a Cellular Assay a PMID 38960086
  • Falanga V, Isseroff RR, Soulika AM, Romanelli M, Margolis D, Kapp S, Granick M, Harding K. Chronic wounds. Nat Rev Dis Primers. 2022 Jul 21;8(1):50. doi: 10.1038/s41572-022-00377-3. PMID 35864102
  • Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x. PMID 19903300
  • Versey Z, da Cruz Nizer WS, Russell E, Zigic S, DeZeeuw KG, Marek JE, Overhage J, Cassol E. Biofilm-Innate Immune Interface: Contribution to Chronic Wound Formation. Front Immunol. 2021 Apr 9;12:648554. doi: 10.3389/fimmu.2021.648554. eCollection 2021. PMID 33897696

Идентификаторы

NCT: NCT07745764 · INJECTHEAL-01 · 2026-3666

Первоисточники (государственные реестры)

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