Platelet Gel in Systemic Sclerosis

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Università Politecnica delle Marche
Updated on 7 November 2020
growth factor
vasodilator
fibrosis
rheumatism
scleroderma
progressive systemic sclerosis
endothelin
prostanoids
prostacyclin
transforming growth factor beta-1

Summary

- Systemic sclerosis (scleroderma; SSc) is a connective tissue disease characterized by a progressive fibrosis of the skin and visceral organs. - A diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to digital ulcers development, responsible for pain, functional disability, disfiguring scars, digital bony reabsorption, infection and osteomyelitis. - Although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has improved the prognosis, digital ulcers are frequently refractory to the medical treatment. - Preliminary data seems to demonstrate a pivotal role played by some growth factors (PDGF, TGF beta 1-2, IGF) in the process of ulcers healing: tissue regeneration and re-epithelization. Alpha-granules in the platelets store these factors in significant amount. - Recently, the application of a gel rich in platelets, prepared from donors’ plasma taken by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing. - On the basis of these considerations we expect that application of a platelet gel, combined with advanced dressing and conventional medical therapy, makes a more rapid healing of digital ulcers in patients with systemic sclerosis. We decided to conduct a double blind RCT to test this hypothesis

Details
Condition Systemic sclerosis
Treatment Platelet Gel
Clinical Study IdentifierNCT00463125
SponsorUniversità Politecnica delle Marche
Last Modified on7 November 2020

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