Platelet Gel in Systemic Sclerosis

Study Overview
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Brief Summary
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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

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

Conditions
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Scleroderma, Systemic

Intervention / Treatment
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* Drug: Platelet Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Platelet Gel|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleroderma, systemic, therapeutic, platelet gel