Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

Efficacy of Platelets Rich Plasma as a Therapeutic Tool in Chronic Non Healing Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03890172
• Other study ID #: Platelets rich plasma
• Status: Not yet recruiting
• Start date: July 30, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Hanaa Mohammed
• Phone: 01094608083
• Email: hanaaried[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

using platelet-rich plasma (PRP) in healing diabetic foot ulcers (DFUs), and to compare the rate of healing and final outcome with conventional therapy.

Description:

Diabetic foot ulcers (DFU) are one of the most frequent and difficult complications in diabetes. The risk for a diabetic patient to develop an ulcer during his life is estimated as being 25%. Ulcers are a frequent cause of lower limbs amputation and 84% of lower limb amputations are preceded by ulcers .

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diabetic patients 18 to 80 years of age, with at least one cutaneous ulcer, which did not improve significantly after at least 4 week ulcer standard treatments

• ankle brachial index value = 0.6

• platelet count = 100,000 /mm 3

• no history of various drug or dressing allergies

Exclusion Criteria:

• - ulcer is due to non diabetic etiology

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

San Sebastian KM, Lobato I, Hernández I, Burgos-Alonso N, Gomez-Fernandez MC, López JL, Rodríguez 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ulcer size	ulcer size will be measured with ruler/probe for length, width and depth and estimated by calculating the ulcer size in centimeter (cm 2).	16 weeks
Secondary	time of wound healing	Complete wound closure over period of 16 weeks	16 weeks