FORCEREPAIR - A Wound Exudate Investigation

NCT06109844 | Completed

• 2 other identifiers: FORCEREPAIR-01104834
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-healing Wound; Cytokines; Venous Leg Ulcer; Wound Healing

Keywords

Venous Leg Ulcer; Varicose Ulcer; Cytokines; Wound Exudate; Wound Healing; Wound Inflammation; Wound Microbiome

Outcome Measures

Primary Outcomes (5)

• Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts

  Proliferation

  Four weeks

• Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts

  Matrix Formation

  Four weeks

• Wound Exudate Effects on Release of Pro-inflammatory Mediators

  Release of pro-inflammatory Mediators

  Four weeks

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

  Gene Expression Profiles

  Four weeks

• Exploratory Wound Exudate Compound and Device Testing

  Wound Exudate Compounds

  Four weeks

Secondary Outcomes (6)

• Wound Exudate Profile Relation to Percentage Area Reduction

  Four Weeks

• 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

• Wound Microbiome 16 rRNA/18sRNA

  Four Weeks

Interventions

Standard of Care OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Danish Wound Healing Center, Bispebjerg Hospital

Copenhagen, Northwest, 2400, Denmark

Location

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

Viborg, 8800, Denmark

Location

Related Publications (12)

• 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

  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.

  PMID: 35742965 BACKGROUND

• 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.

  PMID: 24618232 BACKGROUND

• 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.

  PMID: 32914215 BACKGROUND

• 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.

  PMID: 33897696 BACKGROUND

• 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.

  PMID: 25032070 BACKGROUND

• 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.

  PMID: 26463872 BACKGROUND

• 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.

  PMID: 27566400 BACKGROUND

• 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.

  PMID: 10760211 BACKGROUND

• 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.

  PMID: 29098740 BACKGROUND

• 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.

  PMID: 18179556 BACKGROUND

• 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.

  PMID: 36168150 BACKGROUND

Related Links

• FORCE REPAIR website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Wound exudate (twenty-four-hour-collection with Polyurethane foam discs, Bandages, NovaSwab) Tape strips Wound microbiome swabs

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Frederik Plum, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D Fellow at University of Copenhagen

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: January 24, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be avaible after publication of primary results.
• Access Criteria: Access upon request via email to Principal Investigator.

Locations

DK (2)