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