Platelet Gel in Systemic Sclerosis

April 19, 2007 updated by: Università Politecnica delle Marche

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

  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Rate of complications
Rate of ulcers healed during the follow up period (10 weeks)
Pain evaluation (VAS scale)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Investigators

  • Study Director: Armando Gabrielli, MD, professor, Università Politecnica delle Marche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (ANTICIPATED)

March 1, 2008

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (ESTIMATE)

April 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPM13746IC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe