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Platelet Gel in Systemic Sclerosis

Information source: Universitŗ 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: Universitŗ 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 healing

Rate 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‚Č•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

Page last updated: August 23, 2015

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