Platelet Gel in Systemic Sclerosis

Phase 2

• Conditions: Scleroderma, Systemic

• Registration Number: NCT00463125
• Lead Sponsor: Università Politecnica delle Marche

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Status Verified: 2007-04
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Last Update Submitted: 2007-04-19
• Study First Posted: 2007-04-20
• Last Update Posted: 2007-04-20
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of ulcers healed during the follow up period (10 weeks)
Pain evaluation (VAS scale)
Rate of complications

Trial Locations

Locations (1)

Università politecnica delle marche; 🇮🇹 Ancona, Italy