INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard of care.
- Who it may be relevant to
- Registry conditions: Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INJECTHEAL- Profiling of Potential Wound Healing Therapeutics in Cellular Assays in the Presence of Wound Exudates
Overview
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
- Other standard of care
Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.
Primary outcome measures
- Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts [Time frame: Four weeks]
- Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples [Time frame: Four weeks]
Secondary outcome measures (11)
- Effects of Wound Material and Test Substances on Cell Migration [Time frame: Four weeks]
- Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types [Time frame: Four weeks]
- Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types [Time frame: Four weeks]
- Protein content of wound exudate [Time frame: Four weeks]
- Proteomics profile of wound exudate [Time frame: Four months]
- Bacterial composition of wound biofilm by rRNA16S sequencing [Time frame: Four weeks]
- Correlation of ex vivo/in vitro, biochemical, proteomic, metabolomic, and microbiological findings with routinely collected clinical data [Time frame: Four weeks]
- Effects of Wound Material and Test Substances on Extracellular Matrix Formation [Time frame: 4 weeks]
- Inflammatory Marker Response in Wound-Relevant Cell Types [Time frame: 4 weeks]
- Metabolomics profile of wound exudate [Time frame: 4 months]
- Protease acitivty [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- Heinrich-Heine University, Duesseldorf — Düsseldorf
Publications
- 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
Identifiers
NCT: NCT07745764 · INJECTHEAL-01 · 2026-3666