Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2007-03-31
2008-03-31
Brief Summary
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* 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 Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Platelet Gel
Eligibility Criteria
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Inclusion 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
* Current treatment with Bosentan or Sildenafil
* Presence of necrotic material occluding the wound bed.
18 Years
80 Years
ALL
No
Sponsors
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Università Politecnica delle Marche
OTHER
Principal Investigators
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Armando Gabrielli, MD, professor
Role: STUDY_DIRECTOR
Università Politecnica delle Marche
Locations
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Università politecnica delle marche
Ancona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UPM13746IC
Identifier Type: -
Identifier Source: org_study_id