INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm

N/ANot Yet RecruitingNCT07745764

Barbara Wolff-Winiski72 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

standard of careOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Heinrich-Heine University, Duesseldorf

Düsseldorf, Germany

Outcomes

Primary Outcomes

Wound Exudate and Biofilm Extract Effects on Proliferation of Primary Human Fibroblasts

Proliferation (Optical density)

Time frame: Four weeks

Antibacterial Effects of INJECTHEAL Components on Patient-Specific 3D Wound Biofilm Samples

Bacterial growth (Colony forming units)

Time frame: Four weeks

Secondary Outcomes

Effects of Wound Material and Test Substances on Cell Migration

Cellular migration (Percent surface area covered)

Time frame: Four weeks

Effects of Wound Exudate and/or Biofilm Extracts on Proliferation of Additional Wound-Relevant Cell Types

Proliferation (Optical density)

Time frame: Four weeks

Pro-Inflammatory Cytokine Secretion in Wound-Relevant Cell Types

Measurement of pro-inflammatory cytokines (ng/ml)

Time frame: Four weeks

Protein content of wound exudate

Quantification of total protein (mg/ml)

Time frame: Four weeks

Proteomics profile of wound exudate

Proteomics analysis of wound exudate (-log10(p-value))

Time frame: Four months

Bacterial composition of wound biofilm by rRNA16S sequencing

Bioburden, Diversity and Pathogens

Time frame: Four weeks

Central Contacts

Dr. med. Julian-Dario Rembe, Ph.D.

CONTACT

+49 211 81 - 07163‬‬‬‬‬‬‬‬‬‬‬‬julian-dario.rembe@med.uni-duesseldorf.de

Dr. Barbara Wolff-Winiski, MBA

CONTACT

+43 1 226 2022 02 barbara.wolff-winiski@akribes-biomedical.at

Data from ClinicalTrials.gov

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