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Venous Leg UlcerNCT06109844

FORCEREPAIR - A Wound Exudate Investigation

An observational study of Venous Leg Ulcer and Wound Healing, run by Bispebjerg Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcer, Wound Healing, Non-healing Wound
How many people
13 participants
Where
2 sitesDenmark
Study dates
24 Jan 2024to 1 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Danish Wound Healing Center, Bispebjerg Hospital

    Copenhagen, Northwest, 2400

  • Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital

    Viborg, 8800

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Standard of Care
Keywords
Venous Leg Ulcer, Varicose Ulcer, Cytokines, Wound Exudate, Wound Healing, Wound Inflammation, Wound Microbiome
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of CareOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts

    Proliferation

    Measured: Four weeks

  2. Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts

    Matrix Formation

    Measured: Four weeks

  3. Wound Exudate Effects on Release of Pro-inflammatory Mediators

    Release of pro-inflammatory Mediators

    Measured: Four weeks

  4. Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts

    Gene Expression Profiles

    Measured: Four weeks

  5. Exploratory Wound Exudate Compound and Device Testing

    Wound Exudate Compounds

    Measured: Four weeks

Secondary outcomes (6)

  1. Wound Exudate Profile Relation to Percentage Area Reduction

    Measured: Four Weeks

  2. Wound Exudate Profile Relation to Wound Microbiome Profile

    Measured: Four Weeks

  3. Percentage Area Reduction Relation to Wound Microbiome Profile

    Measured: Four Weeks

  4. Comparisson of Wound Exudate Sampling Techniques

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

    Measured: Four Weeks

  5. Wound Microbiome 16 rRNA/18sRNA

    Bioburden, Diversity and Pathogens

    Measured: Four Weeks

  6. Wound Perilesional Skin Inflammation

    Tape Strips from perilesional skin and control site.

    Measured: Four Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start24 Jan 2024
  3. Primary completion1 Oct 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06109844
Sponsor's protocol ID
FORCEREPAIR-01
Other IDs
104834
Status last verified
Dec 2025
First submitted
26 Oct 2023
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual patient data can be shared anonymized upon contact with PI, after publication of primary results.

Publications

  • Wolff-Winiski, Barbara, Anton Stütz, and Petra Dörfler. "Methods for identifying a non-healing skin wound and for monitoring the healing of a skin wound." U.S. Patent 11,579,141, issued February 14, 2023

  • Burian EA, Sabah L, Karlsmark T, Kirketerp-Moller K, Moffatt CJ, Thyssen JP, Agren MS. Cytokines and Venous Leg Ulcer Healing-A Systematic Review. Int J Mol Sci. 2022 Jun 10;23(12):6526. doi: 10.3390/ijms23126526.

    PubMed 35742965

  • Serra R, Grande R, Buffone G, Molinari V, Perri P, Perri A, Amato B, Colosimo M, de Franciscis S. Extracellular matrix assessment of infected chronic venous leg ulcers: role of metalloproteinases and inflammatory cytokines. Int Wound J. 2016 Feb;13(1):53-8. doi: 10.1111/iwj.12225. Epub 2014 Feb 19.

    PubMed 24618232

  • Tomic-Canic M, Burgess JL, O'Neill KE, Strbo N, Pastar I. Skin Microbiota and its Interplay with Wound Healing. Am J Clin Dermatol. 2020 Sep;21(Suppl 1):36-43. doi: 10.1007/s40257-020-00536-w.

    PubMed 32914215

  • 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.

    PubMed 33897696

  • Misic AM, Gardner SE, Grice EA. The Wound Microbiome: Modern Approaches to Examining the Role of Microorganisms in Impaired Chronic Wound Healing. Adv Wound Care (New Rochelle). 2014 Jul 1;3(7):502-510. doi: 10.1089/wound.2012.0397.

    PubMed 25032070

  • Wolcott RD, Hanson JD, Rees EJ, Koenig LD, Phillips CD, Wolcott RA, Cox SB, White JS. Analysis of the chronic wound microbiota of 2,963 patients by 16S rDNA pyrosequencing. Wound Repair Regen. 2016 Jan-Feb;24(1):163-74. doi: 10.1111/wrr.12370. Epub 2015 Dec 10.

    PubMed 26463872

  • Loesche M, Gardner SE, Kalan L, Horwinski J, Zheng Q, Hodkinson BP, Tyldsley AS, Franciscus CL, Hillis SL, Mehta S, Margolis DJ, Grice EA. Temporal Stability in Chronic Wound Microbiota Is Associated With Poor Healing. J Invest Dermatol. 2017 Jan;137(1):237-244. doi: 10.1016/j.jid.2016.08.009. Epub 2016 Aug 24.

    PubMed 27566400

  • Trengove NJ, Bielefeldt-Ohmann H, Stacey MC. Mitogenic activity and cytokine levels in non-healing and healing chronic leg ulcers. Wound Repair Regen. 2000 Jan-Feb;8(1):13-25. doi: 10.1046/j.1524-475x.2000.00013.x.

    PubMed 10760211

  • Wiegand C, Bittenger K, Galiano RD, Driver VR, Gibbons GW. Does noncontact low-frequency ultrasound therapy contribute to wound healing at the molecular level? Wound Repair Regen. 2017 Sep;25(5):871-882. doi: 10.1111/wrr.12595. Epub 2017 Dec 8.

    PubMed 29098740

  • Ambrosch A, Lobmann R, Pott A, Preissler J. Interleukin-6 concentrations in wound fluids rather than serological markers are useful in assessing bacterial triggers of ulcer inflammation. Int Wound J. 2008 Mar;5(1):99-106. doi: 10.1111/j.1742-481X.2007.00347.x. Epub 2008 Jan 3.

    PubMed 18179556

  • Burian EA, Enevold C, Karlsmark T, Agren MS. A simplified method for monitoring cytokines in wound fluid. Wound Repair Regen. 2023 Jan;31(1):47-55. doi: 10.1111/wrr.13053. Epub 2022 Oct 26.

    PubMed 36168150

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Leg Ulcer and Wound Healing, run by Bispebjerg Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts (time frame: Four weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06109844, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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