Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
Conditions
Keywords
Chronic Wound, Non-healing Wound, Wound healing, Wound Exudate, Wound Biofilm, Wound Microbiome, Fibroblast proliferation, Negative pressure wound therapy, rRNA 16S, Deep cavity wounds, Hydrogel
Brief summary
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.
Detailed description
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.
Interventions
OTHERstandard of care
Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.
Sponsors
Barbara Wolff-Winiski
Heinrich-Heine University, Duesseldorf
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts | Four weeks | Proliferation (Optical density) |
| Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples | Four weeks | Bacterial growth (Colony forming units) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Wound Material and Test Substances on Cell Migration | Four weeks | Cellular migration (Percent surface area covered) |
| Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types | Four weeks | Proliferation (Optical density) |
| Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types | Four weeks | Measurement of pro-inflammatory cytokines (ng/ml) |
| Protein content of wound exudate | Four weeks | Quantification of total protein (mg/ml) |
| Proteomics profile of wound exudate | Four months | Proteomics analysis of wound exudate (-log10(p-value)) |
| Bacterial composition of wound biofilm by rRNA16S sequencing | Four weeks | Bioburden, Diversity and Pathogens |
| Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data | Four weeks | Correlation of laboratory findings with clinical wound trajectory |
| Effects of Wound Material and Test Substances on Extracellular Matrix Formation | 4 weeks | Extracellular Matrix Formation (Optical density) |
| Inflammatory Marker Response in Wound-Relevant Cell Types | 4 weeks | Inflammatory markers (Mean fluorescence intensity) |
| Metabolomics profile of wound exudate | 4 months | Metabolomics analysis of wound exudate (Ion counts) |
| Protease acitivty | 4 weeks | Proteases (nM) |
Countries
Germany
Contacts
CONTACTDr. med. Julian-Dario Rembe, Ph.D.
CONTACTDr. Barbara Wolff-Winiski, MBA
STUDY_DIRECTORDr. Barbara Wolff-Winiski, MBA
Akribes/Biomedical GmbH, Dr. Bohr-Gasse 7 A-1030 Vienna, Austria
PRINCIPAL_INVESTIGATORDr. med. Julian-Dario Rembe, Ph.D.
Heinrich-Heine University, Duesseldorf; Moorenstr. 5 40225 Düsseldorf
Outcome results
None listed