REFERENCES
3C PATCH® IS FORMERLY KNOWN AS LEUCOPATCH
Much of the clinical evidence for the 3C Patch® has been collected under the name LeucoPatch. Scientific evidence is a key element of the product´s development.
3C PATCH® PUBLICATIONS
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 https://dx.doi.org/10.1016/S2213-8587(18)300240
2. Game, F., Jeffcoate, W., Tarnow, L., Day, F., Fitzsimmons, D., & Jacobsen, J. (2017). The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomized controlled trial. Trials, 18(1).
3. Piaggesi A, Läuchli S, Bassetto F, et al. EWMA document: advanced therapies in wound management: cell and tissue based therapies, physical and bio-physical therapies smart and IT based technologies. J Wound Care, 2018; 27(6)Suppl 6.
4. Lundquist, R. (2016). Autologous cell-rich biomaterial (LeucoPatch) in the treatment of diabetic foot ulcers. Book chapter, Wound Healing Biomaterials Vol. 1 Ed. Ågren, M.
5. Thomsen, K., Trøstrup, H., Christophersen, L., Lundquist, R., Høiby, N., & Moser, C. (2016). The phagocytic fitness of leucopatches may impact the healing of chronic wounds. Clinical and Experimental Immunology, 184(3), 368–377.
6. Löndahl, M., Tarnow, L., Karlsmark, T., Lundquist, R., Nielsen, A. M., Michelsen, M., Jørgensen, B. (2015). Use of an autologous leucocyte and platelet-rich fibrin patch on hard-to-heal DFUs: a pilot study. Journal of Wound Care, 24(4), 172–8.
7. Lundquist, R., Holmstrøm, K., Clausen, C., Jørgensen, B., & Karlsmark, T. (2013). Characteristics of an autologous leukocyte and platelet-rich fibrin patch intended for the treatment of recalcitrant wounds. Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society, 21(1), 66–76.
8. Jørgensen, B., Karlsmark, T., Vogensen, H., Haase, L., & Lundquist, R. (2011). A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds. The International Journal of Lower Extremity Wounds, 10(4), 218–23
3C PATCH® PRESENTATIONS
9. Dr. Yousefpour. 3C Patch – background, clinical data and use of a proven autologous therapy. Diabetic lower extremity conference (DLES), Harvard Medical School, Boston 2019.
10. Löndahl M. Lundquist R An autologous fibrin, leucocyte and platelet rich patch (3C Patch) in the healing of hard-to-heal diabetic foot ulcers – outcomes from a large Anglo-Scandinavian RCT. Innovation in Wound Healing, Key West Dec. 2018.
11. Schmidt J. 3C Patch provides autologous immune cells and cytokines relevant for the treatment of Diabetic Foot Ulcers. 5 min Poster presentation. Innovation in Wound Healing, Bahamas 2017.
12. Löndahl M. Clinical experiences with LeucoPatch and status of the large RCT: Leucopatch™ System in the Management of Hard-To- Heal Diabetic Foot Ulcers, part of the “Update in Clinical Trials” session moderated by Dr. Bill Marston, University of North Carolina. Innovation in Wound Healing, Bahamas 2017.
13. Lundquist R. The unique adaptability of living immune cells in wound care is supported by comparing an autologous platelet and leucocyte rich fibrin patch with a dehydrated human amnion/chorion membrane allograft. Innovation in Wound Healing, Miami 2016.
14. Jeffcoate, W. Leucopatch – The Definitive Trial. ETRS, Copenhagen, 2015.
15. Fagher, K. LeucoPatchTM – Clinical Experience. ETRS, Copenhagen, 2015.
16. Thomsen, K. LeucoPatch Anti-Bacterial Properties. ETRS, Copenhagen, 2015.
17. Van Acker. K. LeucoPatch®, a new approach to treat diabetic foot ulcers. Pisa Diabetic Foot Ulcer Course, Pisa, 2015.
18. Jørgensen, B., Löndahl, M., Tarnow, L., Nielsen, A. M., Michelsen, M., Nilsson, A,, Mariusz Zakrzewski, M., Karlsmark, T. Treatment Of Hard-To-Heal Diabetic Foot Ulcers With A Leucocyte And Platelet-Rich Fibrin Patch – A Prospective Scandinavian Multicenter Study. EWMA Meeting, 2013.
19. Löndahl, M., Jørgensen, B., Tarnow, L., Nielsen, A. M., Michelsen, M., Nilsson, A,, Mariusz Zakrzewski, M., Karlsmark, T. LeucoPatch™ seems to improve healing of diabetic foot ulcers – outcome from an open multicenter clinical study.DFSG Meeting, Potsdam, 2012.
3C PATCH® POSTERS
20. Abrebaya, A and Lundquist, R. Clinical experience with the autologous combined leucocyte, platelet, and fibrin patch (3C Patch) in hard-to-heal wounds Poster Innovation in Wound Healing, Florida, 2019.
21. Schmidt J, Berg J, Bonefeld CM, Woetman A. and Lundquist, R. An autologous leukocyte and platelet-rich fibrin patch provides immune cells, cytokines and growth factors relevant for treating diabetic foot ulcers. Poster ISDF, Den Haag, Holland 2019.
22. Schmidt J, Berg J, Bonefeld CM, Woetman A. and Lundquist, R. An autologous leukocyte and platelet-rich fibrin patch provides immune cells, cytokines and growth factors relevant for treating diabetic foot ulcers. Poster EWMA, Gothenburg, Sweden 2019.
23. Schmidt J, Berg J, Bonefeld CM, Woetman A. and Lundquist, R. In vitro study of an autologous leukocyte and platelet-rich fibrin patch for managing diabetic foot ulcers. Poster SAWC Spring, San Antonio, USA 2019.
24. Schmidt J, Bonefeld CM and Lundquist R. 3C Patch® delivers autologous immune cells and growth factors that benefit wound healing in a splinted excisional db/db wound healing model. Poster Innovation in Wound Healing, Key West, USA 2018.
25. Schmidt J, Bonefeld CM and Lundquist R. 3C Patch® delivers autologous immune cells and growth factors that benefit wound healing in a splinted excisional db/db wound healing model. Poster Diabetic lower extremity symposium at Santorini, Greece 2018.
26. Schmidt J, Bonefeld CM, Berg J,and Lundquist, R. Topical treatment with an autologous leukocyte and platelet-rich fibrin patch delivers adequate immune responses and induces wound healing in vitro and in vivo by epidermal proliferation. Poster SAWC Fall, 2018, Las Vegas, USA.
27. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., The LeucoPatch System In The Management of Hard-to-Heal Diabetic Foot Ulcers: A Multicentre, Multinational, Observer-blinded, Randomised Controlled Trial. American Diabetes Association (ADA): Florida: June 2018 P638
28. Schmidt J. 3C Patch provides autologous immune cells and cytokines relevant for the treatment of Diabetic Foot Ulcers. Poster Innovation in Wound Healing, Bahamas 2017.
29. Schmidt, J. 3C Patch derived autologous immune cells deliver immune responses appropriate for the treatment of Diabetic Foot Ulcers, Poster Diabetic lower extremity symposium at Harvard Medical School, Boston November 2017.
30. Schmidt, J. Immunological perspectives of LeucoPatch treatment of Diabetic Foot Ulcers, DFSG Porto September 2017
31. Schmidt, J. The unique adaptability of living immune cells in wound care is supported by comparing an autologous platelet and leucocyte rich fibrin patch with a dehydrated human amnion/chorion membrane allograft. Poster Innovation in Wound Healing, Miami 2016.
32. Lundquist, R., Jørgensen, B., Karlsmark, T., Fagher, K. and Löndahl, M. 3C Patch™ – an adaptive triple layered autologous patch and its clinical use on hard-to-heal diabetic foot ulcers. Poster World Union of Wound Healing Societies, Florence, 2016.
33. Lundquist, R., Jørgensen, B., Fagher, K. and Löndahl, M. 3C Patch™ – an adaptive triple layered autologous platelet and leukocyte rich fibrin patch and its clinical use in the treatment of hard-to-heal diabetic foot ulcers. Poster Innovations in Wound Healing, Miami, 2015.
34. Löndahl, M., Katzman, P., Asmundsson, Å., Ley, M. R., Larsson, G., Ahlberg, M., Fagher, K. Treatment with a Leukocytes and Platelet Rich Fibrin Patch of Recalcitrant Malleoli Ulcers in Patients with Diabetes. Poster (CS-065) SAWC, Las Vegas, 2015.
35. Thomsen, K., Trøstrup, H., Christophersen, L., Lundquist, R., Høiby, N., & Moser, C. Maintained Burst and Phagocytosis Effects of Leucopatches May Terminate Bacterial Biofilms in Chronic Wounds. Abstract ETRS, Copenhagen, 2015.
36. Thomsen, K., Trøstrup, H., Christophersen, L., Lundquist, R., Høiby, N., & Moser, C. Maintained Burst And Phagocytic Competence In Leucopatches May Terminate Bacterial Biofilms In Chronic Wounds. Poster American Society for Microbiology 115th General Meeting, New Orleans, 2015.
37. Buyssens, A., A Moerck, AW,, Perceaux, D., Coessens, V., Van Acker, K. Case report: a patient with silent osteomyelitis receiving chemotherapy. A fully autologous growth factor dressing seems to be an option. Poster ISDF, Den Haag, 2015
38. Fagher, K., Katzman, P., Asmundsson, Å., Ley, M. R., Larsson, G., Ahlberg, M. Löndahl, M. A leukocytes and platelet rich fibrin patch as a novel treatment of malleoli ulcers in patients with diabetes. POSTER ISDF. Den Haag, 2015.
39. Fagher, K., Katzman, P., Asmundsson, Å., Ley, M. R., Larsson, G., Ahlberg, M., … Löndahl, M. (2015). Treatment with a leukocytes and platelet rich fibrin patch on hard-to-heal diabetic foot ulcers probing to bone. POSTER ISDF, 58. Den Haag, 2015.
40. Katzman, P., Fagher, K., Lundquist, R., & Löndahl, M.. Treatment Of Hard-to-heal Diabetic Foot Ulcers Probing To Bone With LeucopatchTM, A Leukocytes And Platelet Rich Fibrin Patch. Poster Abstract (A–4819) 74th ADA Meeting 2014, San Francisco, 2014.
41. Löndahl, M., Larsson, G., Elgzyri, T., Asmundsson, Å., Dupros, I., Ley, M., & Katzman, P. (2013). Treatment of hard-to-heal diabetic foot ulcers probing to bone with an autologous Leucocyte and platelet-rich fibrin patch. Poster EWMA meeting 2013.
42. Löndahl, M., Jørgensen, B., Tarnow, L., Nielsen, A. M., & Michelsen, M. (2012). LeucoPatch seems to improve healing of diabetic foot ulcers – outcome from an open multicenter clinical study. Poster Diabetic Foot Study Groups 10th Annual Meeting. Potsdam; 2012.
43. Karlsmark, T., Lundquist, R., Vogensen, H., Haase, L. and Jørgensen, B. In vitro characterization of an autologous platelet and leukocyte rich fibrin and its clinical use in the treatment of chronic wounds. Poster EWMA Meeting 2012.
GUIDELINE REFERENCES
30. Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T. Sheehan P, Veves A, Wiersma-Bryant L., Guidelines for the Treatment of diabetic ulcers. Wound Repair Regen. 2006; 14(6): 680-692.
49. IGWDF Guideline
OTHER REFERENCES USED ON THIS SITE
31. Serra R, Grande R, Butrico L, Rossi A, Senttimio UF, Caroleo B, Amato B, Gallelli L, de Franciscis S,. Chronic Wound Infections: the role of Pseudonomas aeruginosa and Staphylococcus aureus. Expert Rev Anti Infec Ther. 2015, 13 (5): 605-13.
32. Falanga, V. (2005). Wound healing and its impairment in the diabetic foot. Lancet, 366(9498), 1736–43.
33. Boulton AJ., Vileikyte L., Ragnarson-Tennvall G., Apelqvest J., The global burden of diabetic foot disease. Lancet 2005; 366;1719-24.
34 Prompers L., Huijberts M., Apelqvist J., Jude E., Piagessi A., Bakker K., et al. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study, Diabetologia 2007;50;18-25.
35. Beckman J., Creager M., Libby P., Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA 20002;287:2570-81.
36. Braverman IM. The cutaneous microcirculation.J Invest Dermatol Symp Proc 2000;5:3-9.
37. Rendell MS., Milliken BK., Finnegan MF., Finney DA., Healy JC., The skin blood flow response in wound healing . Microvasc Res 1997; 53 : 222-34.
38. Aller MA., Arias JI., Arraez-Aybar LA., Gilsanz C., Arias J., Wound healing reaction: a switch from gestation to senescence. World J Exp Med 2014; 4:16-26.
39. Mosser DM., Edwards JP., Exploring the full spectrum of macrophage activation. Nat Rev Immunol 2008; 8;958-69.
40. Sun PC., Kuo CD., Chi LY., Lin HD., Wei SH., Chen CS., Microcirculatory vasomotor changes are associated with severity of peripheral neuropathy in patients with type 2 diabetes. Diab Vasc Dis Res 2013; 10:270-6.
41. Galkowska H., Wojewodzka U., Olszewski WL., Low recruitment of immune cells with increased expression of endothelial adhesion molecules in margins of the chronic diabetic foot ulcer. Wound Repair Regen 2005; 13:248-54.
42. Jörneskog G., Why critical limb ischemia criteria are not applicable to diabetic foot and what the consequences ar. Scand J Surg 2012;101: 114-8.
43. Pradhan L., Nabzdyk C., Andersen ND., LoGerfo FW., Veves A., Inflammation and neuropeptides:the connection in diabetic wound healing . Expert Rev Mol Med 2009;11;e2.
44. McInnes AD., Diabetic foot disease in the United Kingdom: about time to put feet first. Foot Ankle Res 2012;5:26.
45. The International Working Group on the Diabetic Foot.
46. Stadler L, Wound Debridement – Robust Growth in a Dynamic Market, SmartTRAK 2018
47. Stevens P, The Cost of Diabetic Foot Ulcers, The O&P Edge, August 2015, seen 19 March 2019 in https://opedge.com/Articles/ViewArticle/2015-08_02
48. Prompers L et al, Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease, Diabetologia, 2008; 51(5): 747–755