Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study

Kepa M San Sebastian, Igone Lobato, Igone Hernández, Natalia Burgos-Alonso, Maria Cruz Gomez-Fernandez, Jose Luis López, Begoña Rodríguez, Anna Giné March, Gonzalo Grandes, Isabel Andia, Kepa M San Sebastian, Igone Lobato, Igone Hernández, Natalia Burgos-Alonso, Maria Cruz Gomez-Fernandez, Jose Luis López, Begoña Rodríguez, Anna Giné March, Gonzalo Grandes, Isabel Andia

Abstract

Background: Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6).

Design: We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week.

Discussion: The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.

Trial registration: Current Controlled Trials NCT02213952.

Figures

Figure 1
Figure 1
Study algorithm.

References

    1. Mast BA. The skin. In: Cohen IK, Diegelmann RF, Lindblad WJ, editors. Wound Healing, Biochemical and Clinical Aspects. Philadelphia, PA: W.B. Saunders; 1992.
    1. Lawrence WT. Clinical management of nonhealing wounds. In: Cohen IK, Diegelmann RF, Lindblad WJ, editors. Wound Healing: Biochemical and Clinical Aspects. Philadelphia, PA: W.B. Saunders; 1992. pp. 541–61.
    1. Gesto-Castromil R, Grupo DETECT-IVC, García JJ. Encuesta epidemiológica realizada en España sobre la prevalencia asistencial de la insuficiencia venosa crónica en atención primaria. Estudio DETECT-IVC. Angiología. 2001;53:249–260.
    1. Brand FN, Dannenberg AL, Abbort RD, Kannel WB. The epidemiology of varicose veins: The Framingham study. Am J Prev Med. 1988;4:96–101.
    1. Stvrtinova V, Kolesar J, Wimmer G. Prevalence of varicose veins of the lower limbs in the women working at a department store. Int Angiol. 1991;10:2–5.
    1. Da Silva A, Wdmer LK, Martin H, Mall T, Glaus L, Schneider M. Varicose veins and chronic venous insufficiency. Vasa. 1974;3:118–25.
    1. Rodríguez-Piñero M. Epidemiología, repercusión sociosanitaria y etiopatogenia de las úlceras vasculares. Angiología. 2003;55:260–267. doi: 10.1016/S0003-3170(03)74801-9.
    1. Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14:680–92.4. doi: 10.1111/j.1524-475X.2006.00176.x.
    1. Bolton LL, van Rijswijk L, Shaffer FA. Quality wound care equals cost-effective wound care: a clinical model. Adv Wound Care. 1997;10:33–8.
    1. Andia I, Abate M. Platelet-rich plasma: underlying biology and clinical correlates. Regen Med. 2013;8(5):645–58. doi: 10.2217/rme.13.59.
    1. Thing J, Maruthappu M, Rogers J. Diagnosis and management of plantar fasciitis in primary care.J. Br J Gen Pract. 2012;62:443–4. doi: 10.3399/bjgp12X653769.
    1. Salazar-Álvarez AE, Riera-del-Moral LF, García-Arranz M, Alvarez-García J, Concepción-Rodriguez NA, Riera-de-Cubas L. Use of platelet-rich plasma in the healing of chronic ulcers of the lower extremity. Actas Dermosifiliogr. 2014;105(6):597–604. doi: 10.1016/j.ad.2013.12.011.
    1. Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, Expósito JA, Bolíbar I, Rodríguez L, Garcia J. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev 2012 Oct 17;10:CD006899 doi: 10.1002/14651858.CD006899.pub2
    1. Sarvajnamurthy S, Suryanarayan S, Budamakuntala L, Suresh DH. Autologous platelet rich plasma in chronic venous ulcers: study of 17 cases. J Cutan Aesthet Surg. 2013;6(2):97–9. doi: 10.4103/0974-2077.112671.
    1. Tzeng YS, Deng SC, Wang CH, Tsai JC, Chen TM, Burnouf T. Treatment of nonhealing diabetic lower extremity ulcers with skin graft and autologous platelet gel: a case series. Biomed Res Int. 2013;2013:837620. doi: 10.1155/2013/837620.
    1. Suryanarayan S, Budamakuntla L, Sha Khadri SI, Sarvajnamurthy S. Efficacy of autologous platelet-rich plasma in the treatment of chronic nonhealing leg ulcers. Plastic Aesthetic Res. 2014;1(2):65–69. doi: 10.4103/2347-9264.139703.
    1. Alonso Verduras C, Baró PazosF, Blanquer Blanquer M, Felipe Fernández P, Fernández Santos ME, Gómez- Chacón C et al., Informe de la Agencia Española de Medicamentos y Productos Sanitarios sobre el uso de Plasma Rico en Plaquetas. Spanish Ministry of Health, Social Services and Equality. 23 May 2013 (Jordi Daniel i Díez Junta Directiva de la SEDAP). Accessed 5 Jan 2015.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera