Platelet Gel in Systemic Sclerosis - Full Text View

Sponsored by:	Università Politecnica delle Marche
Information provided by:	Università Politecnica delle Marche
ClinicalTrials.gov Identifier:	NCT00463125

Purpose

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

Condition	Intervention	Phase
Scleroderma, Systemic	Drug: Platelet Gel	Phase II Phase III

MedlinePlus related topics: Scleroderma

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial

Further study details as provided by Università Politecnica delle Marche:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	40
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2008

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463125

Contacts

Contact: Armando Gabrielli, MD, professor	0712206104 ext 0039	a.gabrielli@univpm.it
Contact: Giovanni Pomponio, MD	0715964205 ext 0039	g.pomponio@ao-umbertoprimo.marche.it

Locations

Italy
Università politecnica delle marche	Recruiting
Ancona, Italy, 60020
Contact: Armando Gabrielli, MD, professor 0712206104 ext 0039 a.gabrielli@univpm.it
Contact: Giovanni Pomponio, MD 0715964205 ext 0039 G.pomponio@ao-umbertoprimo.marche.it

Sponsors and Collaborators

Università Politecnica delle Marche

Investigators

Study Director:

Armando Gabrielli, MD, professor

Università Politecnica delle Marche

More Information

Study ID Numbers:	UPM13746IC
Study First Received:	April 19, 2007
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00463125
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Università Politecnica delle Marche:

Scleroderma, systemic
therapeutic
platelet gel

Study placed in the following topic categories:

Skin Diseases
Ulcer
Connective Tissue Diseases
Sclerosis
Scleroderma, Systemic

ClinicalTrials.gov processed this record on January 16, 2009