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FORCEREPAIR - A Wound Exudate Investigation

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06109844
Collaborator
Akribes Biomedical GmbH (Other), Vascular Research Unit and Department of Vascular Surgery (Other)
20
Enrollment
2
Locations
17
Anticipated Duration (Months)
10
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard of Care

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
FORCEREPAIR - A Wound Exudate Investigation
Anticipated Study Start Date :
Jan 30, 2024
Anticipated Primary Completion Date :
Jan 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Outcome Measures

Primary Outcome Measures

  1. Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts [Four weeks]

    Proliferation

  2. Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts [Four weeks]

    Matrix Formation

  3. Wound Exudate Effects on Release of Pro-inflammatory Mediators [Four weeks]

    Release of pro-inflammatory Mediators

  4. Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts [Four weeks]

    Gene Expression Profiles

  5. Exploratory Wound Exudate Compound and Device Testing [Four weeks]

    Wound Exudate Compounds

Secondary Outcome Measures

  1. Wound Exudate Profile Relation to Percentage Area Reduction [Four Weeks]

  2. Wound Exudate Profile Relation to Wound Microbiome Profile [Four Weeks]

  3. Percentage Area Reduction Relation to Wound Microbiome Profile [Four Weeks]

  4. Comparisson of Wound Exudate Sampling Techniques [Four Weeks]

    Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs

  5. Wound Microbiome 16 rRNA/18sRNA [Four Weeks]

    Bioburden, Diversity and Pathogens

  6. Wound Perilesional Skin Inflammation [Four Weeks]

    Tape Strips from perilesional skin and control site.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danish Wound Healing Center, Bispebjerg Hospital Copenhagen Northwest Denmark 2400
2 Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital Viborg Denmark 8800

Sponsors and Collaborators

  • Bispebjerg Hospital
  • Akribes Biomedical GmbH
  • Vascular Research Unit and Department of Vascular Surgery

Investigators

  • Principal Investigator: Frederik Plum, MD, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Frederik Plum, MD, Ph.D Fellow at University of Copenhagen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT06109844
Other Study ID Numbers:
  • FORCEREPAIR-01
  • 104834
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frederik Plum, MD, Ph.D Fellow at University of Copenhagen, Bispebjerg Hospital
Venous Leg Ulcer
Varicose Ulcer
Cytokines
Wound Exudate
Wound Healing
Wound Inflammation
Wound Microbiome
Additional relevant MeSH terms:
Varicose Ulcer
Leg Ulcer
Wounds and Injuries

Study Results

No Results Posted as of Oct 31, 2023