FORCEREPAIR - A Wound Exudate Investigation

October 26, 2023 updated by: Frederik Plum, Bispebjerg Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Viborg, Denmark, 8800
        • Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital
        • Contact:
    • Northwest
      • Copenhagen, Northwest, Denmark, 2400
        • Danish Wound Healing Center, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Twenty patients with venous leg ulcers, verified by a wound expert, will be included in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts
Time Frame: Four weeks
Proliferation
Four weeks
Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts
Time Frame: Four weeks
Matrix Formation
Four weeks
Wound Exudate Effects on Release of Pro-inflammatory Mediators
Time Frame: Four weeks
Release of pro-inflammatory Mediators
Four weeks
Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts
Time Frame: Four weeks
Gene Expression Profiles
Four weeks
Exploratory Wound Exudate Compound and Device Testing
Time Frame: Four weeks
Wound Exudate Compounds
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Exudate Profile Relation to Percentage Area Reduction
Time Frame: Four Weeks
Four Weeks
Wound Exudate Profile Relation to Wound Microbiome Profile
Time Frame: Four Weeks
Four Weeks
Percentage Area Reduction Relation to Wound Microbiome Profile
Time Frame: Four Weeks
Four Weeks
Comparisson of Wound Exudate Sampling Techniques
Time Frame: Four Weeks
Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs
Four Weeks
Wound Microbiome 16 rRNA/18sRNA
Time Frame: Four Weeks
Bioburden, Diversity and Pathogens
Four Weeks
Wound Perilesional Skin Inflammation
Time Frame: Four Weeks
Tape Strips from perilesional skin and control site.
Four Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Akribes Biomedical GmbH
Vascular Research Unit and Department of Vascular Surgery

Investigators

  • Principal Investigator: Frederik Plum, MD, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORCEREPAIR-01
  • 104834 (Registry Identifier: Research Ethics Comittee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data can be shared anonymized upon contact with PI, after publication of primary results.

IPD Sharing Time Frame

Data will be avaible after publication of primary results.

IPD Sharing Access Criteria

Access upon request via email to Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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