- 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