رادار التجارب AI | ||
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حالة التجربة السريرية NCT06109844 لـ قرحة الساق الوريدية، التئام الجروح، جرح غير ملتئم، السيتوكينات هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
FORCEREPAIR - A Wound Exudate Investigation
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06109844 هي دراسة رصدية لـقرحة الساق الوريدية، التئام الجروح، جرح غير ملتئم، السيتوكينات وهي قيد التجنيد. بدأت في ١٢ رجب ١٤٤٥ هـ مع خطة لتجنيد ٢٠ مشاركًا. يقودها Bispebjerg Hospital، ومن المتوقع اكتمالها بحلول ٥ محرم ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٣ محرم ١٤٤٦ هـ.
الملخص
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.
وصف مفصل
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.
العنوان الرسمي
FORCEREPAIR - A Wound Exudate Investigation
الحالات الطبية
قرحة الساق الوريديةالتئام الجروحجرح غير ملتئمالسيتوكيناتالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
معرّفات دراسة أخرى
- FORCEREPAIR-01
- 104834 (معرف السجل) (Research Ethics Comittee)
NCT معرّف
تاريخ البدء (فعلي)
2024-01-24
آخر تحديث مُنشور
2024-07-09
تاريخ الاكتمال (المقدر)
2025-06-30
عدد المشاركين المخطط لهم
٢٠
نوع الدراسة
رصدية
الحالة
قيد التجنيد
الكلمات الرئيسية
Venous Leg Ulcer
Varicose Ulcer
Cytokines
Wound Exudate
Wound Healing
Wound Inflammation
Wound Microbiome
Varicose Ulcer
Cytokines
Wound Exudate
Wound Healing
Wound Inflammation
Wound Microbiome
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
غ/م | معيار الرعاية Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 | 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 |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- 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
- 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
Akribes Biomedical GmbH
Vascular Research Unit and Department of Vascular Surgery
الجهة المسؤولة عن الدراسة
Frederik Plum, المحقق الرئيسي, MD, Ph.D Fellow at University of Copenhagen, Bispebjerg Hospital
جهة اتصال مركزية للدراسة
جهة اتصال: Frederik Plum, MD, +4529671247, [email protected]
جهة اتصال: Klaus Kirketerp-Møller, MD, Ph.D, +4540199087, [email protected]
2 مواقع الدراسة في 1 بلدان
Northwest
Danish Wound Healing Center, Bispebjerg Hospital, Copenhagen, Northwest, 2400, Denmark
Frederik Plum, MD, جهة اتصال, +4529671247, [email protected]
Klaus Kirketerp-Møller, Consultant, جهة اتصال, +4540199087, [email protected]
Frederik Plum, MD, المحقق الرئيسي
قيد التجنيد
Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital, Viborg, 8800, Denmark
Annette Høgh, MD, جهة اتصال, [email protected]
قيد التجنيد