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Platelet Gel in Systemic Sclerosis

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463125
Enrollment
40
Registered
2007-04-20
Start date
2007-03-31
Completion date
2008-03-31
Last updated
2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Systemic

Keywords

Scleroderma, systemic, therapeutic, platelet gel

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

Interventions

Sponsors

Università Politecnica delle Marche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Digital ulcers (NPUAP stage≥2) in patients with SSc (ACR 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

* Clinical evidence of skin infection * Current treatment with Bosentan or Sildenafil * Presence of necrotic material occluding the wound bed.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactArmando Gabrielli, MD, professor
a.gabrielli@univpm.it0712206104
Backup ContactGiovanni Pomponio, MD
g.pomponio@ao-umbertoprimo.marche.it0715964205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026