Platelet Gel in Systemic Sclerosis

NCT00463125 | Unknown Phase 2

• 1 other identifier: UPM13746IC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Scleroderma, Systemic

Keywords

Scleroderma, systemic; therapeutic; platelet gel

Outcome Measures

Primary Outcomes (2)

• Time from diagnosis to complete ulcer healing

• Rate of ulcers healed during the follow up period (10 weeks)

Secondary Outcomes (3)

• Rate of ulcers healed during the follow up period (10 weeks)

• Pain evaluation (VAS scale)

• Rate of complications

Interventions

Platelet Gel DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Università politecnica delle marche

Ancona, 60020, Italy

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Armando Gabrielli, MD, professor

  Università Politecnica delle Marche

  STUDY DIRECTOR

Central Study Contacts

Armando Gabrielli, MD, professor

CONTACT

0712206104; a.gabrielli@univpm.it

Giovanni Pomponio, MD

CONTACT

0715964205; g.pomponio@ao-umbertoprimo.marche.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: March 1, 2007
• Study Completion: March 1, 2008
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

IT (1)