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| ID | Type | Description | Link |
|---|---|---|---|
| 104834 | Registry Identifier | Research Ethics Comittee |
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| Name | Class |
|---|---|
| Akribes Biomedical GmbH | UNKNOWN |
| Vascular Research Unit and Department of Vascular Surgery | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty patients with venous leg ulcers, verified by a wound expert, will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Plum, MD | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Wound Healing Center, Bispebjerg Hospital | Copenhagen | Northwest | 2400 | Denmark | ||
| Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 35742965 | 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. | |
| 24618232 |
| Label | URL |
|---|---|
| FORCE REPAIR website | View source |
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Individual patient data can be shared anonymized upon contact with PI, after publication of primary results.
Data will be avaible after publication of primary results.
Access upon request via email to Principal Investigator.
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Wound exudate (twenty-four-hour-collection with Polyurethane foam discs, Bandages, NovaSwab) Tape strips Wound microbiome swabs
| Four Weeks |
| Comparisson of Wound Exudate Sampling Techniques | Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs | Four Weeks |
| Wound Microbiome 16 rRNA/18sRNA | Bioburden, Diversity and Pathogens | Four Weeks |
| Wound Perilesional Skin Inflammation | Tape Strips from perilesional skin and control site. | Four Weeks |
| Viborg |
| 8800 |
| Denmark |
| 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. |
| 32914215 | 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. |
| 33897696 | 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. |
| 25032070 | 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. |
| 26463872 | 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. |
| 27566400 | 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. |
| 10760211 | 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. |
| 29098740 | 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. |
| 18179556 | 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. |
| 36168150 | 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. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |