Platelet Gel in Systemic Sclerosis
Information source: Università Politecnica delle Marche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scleroderma, Systemic
Intervention: Platelet Gel (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Università Politecnica delle Marche Official(s) and/or principal investigator(s): Armando Gabrielli, MD, professor, Study Director, Affiliation: Università Politecnica delle Marche
Overall contact: Armando Gabrielli, MD, professor, Phone: 0712206104, Ext: 0039, Email: a.gabrielli@univpm.it
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
Clinical Details
Official title: Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Time from diagnosis to complete ulcer healingRate of ulcers healed during the follow up period (10 weeks)
Secondary outcome: Rate of ulcers healed during the follow up period (10 weeks)Pain evaluation (VAS scale) Rate of complications
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Armando Gabrielli, MD, professor, Phone: 0712206104, Ext: 0039, Email: a.gabrielli@univpm.it
Università politecnica delle marche, Ancona 60020, Italy; Recruiting Armando Gabrielli, MD, professor, Phone: 0712206104, Ext: 0039, Email: a.gabrielli@univpm.it Giovanni Pomponio, MD, Phone: 0715964205, Ext: 0039, Email: G.pomponio@ao-umbertoprimo.marche.it
Additional Information
Starting date: March 2007
Last updated: April 19, 2007
|