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NCT06109844 Clinical Trial

FORCEREPAIR - A Wound Exudate Investigation

Venous Leg Ulcer Clinical Trial

Official title:
FORCEREPAIR - A Wound Exudate Investigation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06109844
Other study ID # FORCEREPAIR-01
Secondary ID 104834
Status Not yet recruiting
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date June 30, 2025

Study information
Verified date October 2023
Source Bispebjerg Hospital
Contact Frederik Plum, MD
Phone +4529671247
Email frederik6@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Each patient is seen four times where wound exudate and the bacteria microbiome are sampled and wound size is monitored with advanced planimetric tools.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Danish Wound Healing Center, Bispebjerg Hospital Copenhagen Northwest
Denmark Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital Viborg

Sponsors (3)
Lead Sponsor Collaborator
Bispebjerg Hospital Akribes Biomedical GmbH, Vascular Research Unit and Department of Vascular Surgery

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts Proliferation Four weeks
Primary Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts Matrix Formation Four weeks
Primary Wound Exudate Effects on Release of Pro-inflammatory Mediators Release of pro-inflammatory Mediators Four weeks
Primary Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts Gene Expression Profiles Four weeks
Primary Exploratory Wound Exudate Compound and Device Testing Wound Exudate Compounds Four weeks
Secondary Wound Exudate Profile Relation to Percentage Area Reduction Four Weeks
Secondary Wound Exudate Profile Relation to Wound Microbiome Profile Four Weeks
Secondary Percentage Area Reduction Relation to Wound Microbiome Profile Four Weeks
Secondary Comparisson of Wound Exudate Sampling Techniques Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs Four Weeks
Secondary Wound Microbiome 16 rRNA/18sRNA Bioburden, Diversity and Pathogens Four Weeks
Secondary Wound Perilesional Skin Inflammation Tape Strips from perilesional skin and control site. Four Weeks
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