Platelet Gel in Systemic Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Università Politecnica delle Marche.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università Politecnica delle Marche
ClinicalTrials.gov Identifier:
NCT00463125
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose
  • 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
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463125

Contacts
Contact: Armando Gabrielli, MD, professor 0712206104 ext 0039 a.gabrielli@univpm.it
Contact: Giovanni Pomponio, MD 0715964205 ext 0039 g.pomponio@ao-umbertoprimo.marche.it

Locations
Italy
Università politecnica delle marche Recruiting
Ancona, Italy, 60020
Contact: Armando Gabrielli, MD, professor    0712206104 ext 0039    a.gabrielli@univpm.it   
Contact: Giovanni Pomponio, MD    0715964205 ext 0039    G.pomponio@ao-umbertoprimo.marche.it   
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
Study Director: Armando Gabrielli, MD, professor Università Politecnica delle Marche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463125     History of Changes
Other Study ID Numbers: UPM13746IC
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014