Platelet Gel in Systemic Sclerosis

• Status: Unknown status
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università Politecnica delle Marche

Criteria

Inclusion Criteria:

• Digital ulcers (NPUAP stage≥2) in patients with SSc (ACR criteria)

• Current medical treatment with intravenous prostanoids

• Availability to come to our centre for weekly ulcer assessment and medication

• Capacity to give informed consent

Exclusion Criteria:

• Clinical evidence of skin infection

• Current treatment with Bosentan or Sildenafil

• Presence of necrotic material occluding the wound bed.