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

NCT03890172 | Unknown

• 1 other identifier: Platelets rich plasma
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer

Keywords

platelets rich plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• time of wound healing

  16 weeks

Study Arms (2)

study group

in this group the investigators will be managing diabetic wounds with platelet rich plasma treatment.

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

control group

In this group patients will receive the standard treatment in form of debridement and dressing twice weekly

Other: standard treatment

Interventions

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 OTHER

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)

study group

standard treatment OTHER

Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

, The study included 60 patients of both sex from 18 to 80 years, with clean chronic diabetic foot ulcers divided into 2 equal groups. The study group in which PRP was used, and the control group receiving standard therapy The formed PRP was applied to the wound twice weekly.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (14)

• 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.

  PMID: 20967164 BACKGROUND

• 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.

  PMID: 27483482 BACKGROUND

• 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.

  PMID: 18442162 BACKGROUND

• 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.

  PMID: 29377202 BACKGROUND

• 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.

  PMID: 27839965 BACKGROUND

• 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.

  PMID: 29457008 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25547983 BACKGROUND

• 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.

  PMID: 23998756 BACKGROUND

• 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.

  PMID: 17595032 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24004354 BACKGROUND

• 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.

  PMID: 22028946 BACKGROUND

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

  PMID: 20351977 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Hanan Mohamoud

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hanaa Mohammed

CONTACT

01094608083; hanaaried@gmail.com

Essam Abdelmohsen

CONTACT

01001971906; dressam@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 26, 2019
• Study Start: July 30, 2019
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

EG (1)