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Platelet Gel in Systemic Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Università Politecnica delle Marche.
Recruitment status was:  Recruiting
Information provided by:
Università Politecnica delle Marche Identifier:
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  • 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

Condition Intervention Phase
Scleroderma, Systemic
Drug: Platelet Gel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Università Politecnica delle Marche:

Primary Outcome Measures:
  • Time from diagnosis to complete ulcer healing
  • Rate of ulcers healed during the follow up period (10 weeks)

Secondary Outcome Measures:
  • Rate of ulcers healed during the follow up period (10 weeks)
  • Pain evaluation (VAS scale)
  • Rate of complications

Estimated Enrollment: 40
Study Start Date: March 2007
Estimated Study Completion Date: March 2008

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00463125

Contact: Armando Gabrielli, MD, professor 0712206104 ext 0039
Contact: Giovanni Pomponio, MD 0715964205 ext 0039

Università politecnica delle marche Recruiting
Ancona, Italy, 60020
Contact: Armando Gabrielli, MD, professor    0712206104 ext 0039   
Contact: Giovanni Pomponio, MD    0715964205 ext 0039   
Sponsors and Collaborators
Università Politecnica delle Marche
Study Director: Armando Gabrielli, MD, professor Università Politecnica delle Marche
  More Information Identifier: NCT00463125     History of Changes
Other Study ID Numbers: UPM13746IC
Study First Received: April 19, 2007
Last Updated: April 19, 2007

Keywords provided by Università Politecnica delle Marche:
Scleroderma, systemic
platelet gel

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases processed this record on May 25, 2017