Scleroderma, SystemicPhase 2/3NCT00463125
Platelet Gel in Systemic Sclerosis
A Phase 2/3 study testing Platelet Gel in people with Scleroderma, Systemic, run by Università Politecnica delle Marche at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Platelet Gel
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Mar 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical evidence of skin infection
- Current treatment with Bosentan or Sildenafil
- Presence of necrotic material occluding the wound bed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università politecnica delle marche
Ancona, 60020
Armando Gabrielli, MD, professor, 0712206104 ext. 0039, a.gabrielli@univpm.it
Giovanni Pomponio, MD, 0715964205 ext. 0039, G.pomponio@ao-umbertoprimo.marche.it
About this study
Official title: 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
- Conditions
- Scleroderma, Systemic
- Being tested
- Platelet Gel
- Keywords
- Scleroderma, systemic, therapeutic, platelet gel
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet GelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from diagnosis to complete ulcer healing
Rate of ulcers healed during the follow up period (10 weeks)
Secondary outcomes (3)
Rate of ulcers healed during the follow up period (10 weeks)
Pain evaluation (VAS scale)
Rate of complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startMar 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Investigators
- Armando Gabrielli, MD, professor, Study director, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463125
- Sponsor's protocol ID
- UPM13746IC
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00463125
- Acronym / sponsor ID
- UPM13746IC
- Conditions
- Scleroderma, Systemic
- Keywords
- Scleroderma, systemic, therapeutic, platelet gel
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Clinical evidence of skin infection
- Current treatment with Bosentan or Sildenafil
- Presence of necrotic material occluding the wound bed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Gel | Drug | – |
Primary outcome
Time from diagnosis to complete ulcer healing
Rate of ulcers healed during the follow up period (10 weeks)
3 secondary outcomes
Rate of ulcers healed during the follow up period (10 weeks)
Pain evaluation (VAS scale)
Rate of complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Gabrielli, MD, professor study director
Università Politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet Gel in people with Scleroderma, Systemic, run by Università Politecnica delle Marche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armando Gabrielli, MD, professor (0712206104 ext. 0039, a.gabrielli@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from diagnosis to complete ulcer healing. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.