Platelet Gel in Systemic Sclerosis

Status Recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00463125
Study type	Interventional
Source	Università Politecnica delle Marche
Contact	Armando Gabrielli, MD, professor
Phone	0712206104
Email	a.gabrielli@univpm.it
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	March 2007
Completion date	March 2008

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See also
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Completed	`NCT00442611` - A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)	Phase 1/Phase 2
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