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FORCEREPAIR - A Wound Exudate Investigation

NCT ID: NCT06109844

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-24

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Venous Leg Ulcer Wound Healing Non-healing Wound Cytokines

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Standard of Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akribes Biomedical GmbH

UNKNOWN

Sponsor Role collaborator

Vascular Research Unit and Department of Vascular Surgery

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederik Plum

MD, Ph.D Fellow at University of Copenhagen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederik Plum, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Danish Wound Healing Center, Bispebjerg Hospital

Copenhagen, Northwest, Denmark

Site Status

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

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35742965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24618232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32914215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33897696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25032070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26463872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27566400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10760211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29098740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18179556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36168150 (View on PubMed)

Related Links

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https://www.forcerepair-wounds.eu/

FORCE REPAIR website

Other Identifiers

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104834

Identifier Type: REGISTRY

Identifier Source: secondary_id

FORCEREPAIR-01

Identifier Type: -

Identifier Source: org_study_id