Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers
NCT ID: NCT03890172
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2019-07-30
2021-12-30
Brief Summary
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Detailed Description
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Diabetic ulcer (DU) is not only a serious clinical problem with negative impacts on both the life quality and survival time, but also an economic burden with significant contribution to high cost and lengthy hospitalizations. Furthermore, the non healing diabetic cutaneous ulcers along with the subsequent amputations may bring about costly to treat and painful disabilities. However, healing of the DU may be improved and most of the amputations may be prevented by more effective treatments based on diabetic education .
In spite of the high prevalence and morbidity associated with DFUs, current treatment options are limited. Current standard management consists of surgical debridement followed by frequent dressing changes with tight infection and glycemic control. Despite this comprehensive approach, complication and amputation rates remain high.
The use of platelet-rich plasma (PRP) has emerged as an adjunctive method for treating DFUs.
Platelet-rich plasma (PRP) preparations were first described in the 1980s as plasma with a platelet count above that found normally in peripheral blood.
First used in the field of hematology, PRP use has expanded throughout the fields of dermatology, oral-maxillofacial surgery, plastic surgery, cardiac surgery, ophthalmology, urology, and gynecology .
The concentration of platelets in PRP is 2-6 folds higher than that of whole blood .
The curative properties of PRP rely on the fact that platelets are a physiological reservoir of a variety of growth factors, with healing function which have an active role in tissue regeneration .
Platelets contain proteins, known as growth factors that trigger biological effects including directed cell migration (i.e. chemotaxis), angiogenesis, cell proliferation and differentiation, which are key elements in the process of tissue repair and regeneration.
Specifically, the platelet alpha-granules contain several of these molecules, including: platelet derived growth factor (PDGF),transforming growth factor B ( TGF-β), vascular endothelial growth factor (VEGF), epithelial growth factor (EGF), fibrinogen, fibronectin, and vitronectin.
In addition, platelet delta granules contain serotonin, histamine, dopamine, calcium, and adenosine, which act in tandem with the aforementioned growth factors to regulate wound healing .
platelets exert antimicrobial activity against some bacteria of the skin, and clinical data shows that the presence of infection is reduced in PRP-treated wounds.
The advantages and merits of PRP are apparent since it is easy, cost-effective and much more lasting compared to other standard treatments and being autologous in nature, it is free from communicable pathogens, making it a safe treatment modality with good clinical results
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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study group
in this group the investigators will be managing diabetic wounds with platelet rich plasma treatment.
20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly
topical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc)
control group
In this group patients will receive the standard treatment in form of debridement and dressing twice weekly
standard treatment
Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.
Interventions
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20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly
topical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc)
standard treatment
Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.
Eligibility Criteria
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Inclusion Criteria
* ankle brachial index value ≥ 0.6
* platelet count ≥ 100,000 /mm 3
* no history of various drug or dressing allergies
Exclusion Criteria
* patients blood vessels are non compressible for ankle brachial index (ABI )testing
* the presence of an infected wound and/or osteomyelitis, and/or a completely necrotic ulcer
* active oncological disease. systemic treatment medications like corticosteroids, immunosuppressive agents, as well as radiation or chemotherapy at the target sites within 3 weeks before this study.
* Screening platelets count less than 100,000mm3
* Screening hemoglobin less than10.5mg/dl
* End stages renal disease,haematological,collagen vascular disease and bleeding disorders
18 Years
80 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hanaa Mohammed Riad
assistant lecture
Principal Investigators
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Hanan Mohamoud
Role: STUDY_DIRECTOR
Assiut University
Locations
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Assiut University
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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essam abdelmohsen
Role: primary
References
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Bernuzzi G, Tardito S, Bussolati O, Adorni D, Cantarelli S, Fagnoni F, Rossetti A, Azzarone M, Ficarelli E, Caleffi E, Gazzola G, Franchini M. Platelet gel in the treatment of cutaneous ulcers: the experience of the Immunohaematology and Transfusion Centre of Parma. Blood Transfus. 2010 Oct;8(4):237-47. doi: 10.2450/2009.0118-09.
Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
Apelqvist J, Bakker K, van Houtum WH, Schaper NC; International Working Group on the Diabetic Foot (IWGDF) Editorial Board. The development of global consensus guidelines on the management of the diabetic foot. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S116-8. doi: 10.1002/dmrr.832.
Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
Mohammadi MH, Molavi B, Mohammadi S, Nikbakht M, Mohammadi AM, Mostafaei S, Norooznezhad AH, Ghorbani Abdegah A, Ghavamzadeh A. Evaluation of wound healing in diabetic foot ulcer using platelet-rich plasma gel: A single-arm clinical trial. Transfus Apher Sci. 2017 Apr;56(2):160-164. doi: 10.1016/j.transci.2016.10.020. Epub 2016 Nov 2.
Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
Andia E R-AJ, Martin I, Abate M. Current concepts and translational uses of platelet rich plasma biotechnology. Biotechnology 2015. https://doi.org/10.5772/59954 Google Scholar
San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8.
Andia I, Abate M. Platelet-rich plasma: underlying biology and clinical correlates. Regen Med. 2013 Sep;8(5):645-58. doi: 10.2217/rme.13.59.
Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. doi: 10.1002/jbm.b.30886.
Kakudo N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32. N, Kushida S, Ogura N, Hara T, Suzuki K. The use of autologous platelet rich plasma in the treatment of intractable skin ulcer. Open J Reg Med. 2012;1:29-32.
Liao HT, Marra KG, Rubin JP. Application of platelet-rich plasma and platelet-rich fibrin in fat grafting: basic science and literature review. Tissue Eng Part B Rev. 2014 Aug;20(4):267-76. doi: 10.1089/ten.TEB.2013.0317. Epub 2013 Dec 18.
Carter MJ, Fylling CP, Parnell LK. Use of platelet rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. 2011;11:e38. Epub 2011 Sep 15.
Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
Other Identifiers
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Platelets rich plasma
Identifier Type: -
Identifier Source: org_study_id
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