Platelet Gel in Systemic Sclerosis

Scleroderma, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00463125
• Other study ID #: UPM13746IC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 19, 2007
• Last updated: April 19, 2007
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2007
• Source: Università Politecnica delle Marche
• Contact: Armando Gabrielli, MD, professor
• Phone: 0712206104
• Email: a.gabrielli[@]univpm.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Drug:
• Platelet Gel

Locations

Country	Name	City	State
Italy	Università politecnica delle marche	Ancona

Sponsors (1)

Lead Sponsor	Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from diagnosis to complete ulcer healing
Primary	Rate of ulcers healed during the follow up period (10 weeks)
Secondary	Rate of ulcers healed during the follow up period (10 weeks)
Secondary	Pain evaluation (VAS scale)
Secondary	Rate of complications