INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

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.

Inclusion criteria

• 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

Exclusion criteria

• 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