Clinical Trial: Platelet Gel in Systemic Sclerosis

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial

Brief 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

Detailed Summary:
Sponsor: Università Politecnica delle Marche

Current Primary Outcome:

  • Time from diagnosis to complete ulcer healing
  • Rate of ulcers healed during the follow up period (10 weeks)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of ulcers healed during the follow up period (10 weeks)
  • Pain evaluation (VAS scale)
  • Rate of complications


Original Secondary Outcome: Same as current

Information By: Università Politecnica delle Marche

Dates:
Date Received: April 19, 2007
Date Started: March 2007
Date Completion: March 2008
Last Updated: April 19, 2007
Last Verified: April 2007