INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts
时间窗: Four weeks
Proliferation (Optical density)
Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples
时间窗: Four weeks
Bacterial growth (Colony forming units)
次要结局
- Effects of Wound Material and Test Substances on Cell Migration(Four weeks)
- Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types(Four weeks)
- Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types(Four weeks)
- Protein content of wound exudate(Four weeks)
- Proteomics profile of wound exudate(Four months)
- Bacterial composition of wound biofilm by rRNA16S sequencing(Four weeks)
- Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data(Four weeks)
- Effects of Wound Material and Test Substances on Extracellular Matrix Formation(4 weeks)
- Inflammatory Marker Response in Wound-Relevant Cell Types(4 weeks)
- Metabolomics profile of wound exudate(4 months)
- Protease acitivty(4 weeks)
研究者
Barbara Wolff-Winiski
Chief Scientific Officer
Akribes Biomedical GmbH