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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00463125 |
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Date of registration:
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19/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Platelet Gel in Systemic Sclerosis
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Scientific title:
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Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00463125 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Armando Gabrielli, MD, professor |
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Address:
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Telephone:
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0712206104 |
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Email:
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a.gabrielli@univpm.it |
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Affiliation:
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Name:
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Armando Gabrielli, MD, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Università Politecnica delle Marche |
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Name:
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Armando Gabrielli, MD, professor |
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Address:
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Telephone:
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0712206104 |
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Email:
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a.gabrielli@univpm.it |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scleroderma, Systemic
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Intervention(s)
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Drug: Platelet Gel
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Primary Outcome(s)
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Time from diagnosis to complete ulcer healing
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Rate of ulcers healed during the follow up period (10 weeks)
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Secondary Outcome(s)
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Pain evaluation (VAS scale)
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Rate of complications
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Rate of ulcers healed during the follow up period (10 weeks)
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Secondary ID(s)
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UPM13746IC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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