Cytokines, Non-healing Wound, Venous Leg Ulcer, Wound Healing
Conditions
Keywords
Venous Leg Ulcer, Varicose Ulcer, Cytokines, Wound Exudate, Wound Healing, Wound Inflammation, Wound Microbiome
Brief summary
The observational longitudinal study will collect wound exudate from twenty patients with venous leg ulcers. Wound exudate samples are collected using twenty-four-hour collection with polyurethane foam, bandages and the NovaSwab method. Each patient is seen four times where wound exudate and the bacteria microbiome are sampled and wound size is monitored with advanced planimetric tools.
Detailed description
This dual centre longitudinal observational study will run from January 2024 to January 2025. The investigation will include twenty patients over four weeks including four study visits. Sampling of wound exudate can take place on every visit and will be made with the polyurethane discs, the NovaSwab technique and waste bandages. The wound bacteria microbiome is sampled with routine bacterial swabs. Tape strips will be used to assess perilesional skin and control sites of normal skin and will primarily measure skin inflammation parameters. Clinical pictures are taken and analysed using advanced planimetric tools. Patients enrolled receive standard wound care; allowing all kinds of dressing. However when consenting to twenty-four-hour-collection patients will not be allowed to wear active bandages or receive antibiotic treatment for that period. Compression, wound dressings, and use of topical and oral antibiotics will be registered. For the storage of samples, a research biobank is used, and leftover material will be stored in a biobank for future research.
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
Akribes Biomedical GmbH
Vascular Research Unit and Department of Vascular Surgery
Bispebjerg Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults fulfilling all inclusion criteria * Age \>18 years * Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification) * Wound Area equal to or above 1 cm2 (measured with a ruler length x width) * Patient can understand Danish * Patient can comply with protocol * Patient is fully informed about the study and has given informed consent
Exclusion criteria
* Venous leg ulcer with communication to bone * Known or suspected cancer in the wound * Allergies towards products used in the study, e.g. polyurethane foam and tegaderm * Dementia * Judgement by the investigator that the patient is not suited for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts | Four weeks | Proliferation |
| Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts | Four weeks | Matrix Formation |
| Wound Exudate Effects on Release of Pro-inflammatory Mediators | Four weeks | Release of pro-inflammatory Mediators |
| Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts | Four weeks | Gene Expression Profiles |
| Exploratory Wound Exudate Compound and Device Testing | Four weeks | Wound Exudate Compounds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Exudate Profile Relation to Percentage Area Reduction | Four Weeks | — |
| Wound Perilesional Skin Inflammation | Four Weeks | Tape Strips from perilesional skin and control site. |
| Wound Exudate Profile Relation to Wound Microbiome Profile | Four Weeks | — |
| Percentage Area Reduction Relation to Wound Microbiome Profile | Four Weeks | — |
| Comparisson of Wound Exudate Sampling Techniques | Four Weeks | Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs |
| Wound Microbiome 16 rRNA/18sRNA | Four Weeks | Bioburden, Diversity and Pathogens |
Countries
Denmark
Outcome results
None listed