Active Digital UlcersPhase 2SildenafilNCT00624273
Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis
A Phase 2 study testing Sildenafil therapy in people with Active Digital Ulcers, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Active Digital Ulcers
- What is being tested?
- Sildenafil therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Feb 2007
- Phase
- Phase 2
- 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 gangrene, ulcers in patients with severe secondary Raynaud's phenomenon
- Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.
- Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
- No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy
Who cannot join
- Therapy with iloprost during the last 4 weeks
- Sympathectomy during the last 4 weeks
- TIA, stroke, myocardial infarction during the last 6 months
- Instable angina pectoris
- Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
- Microangiopathic hemolytic anaemia
Show all 16Show fewer
- Azotaemia
- Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)
- Left ventricular ejection fraction< 20%
- Hypotonus < 80/40 mm Hg
- Positive pregnancy test
- History of cancer
- History of gastric/duodenic ulcers without endoscopic proof of complete healing
- Participation in other studies (currently or during the last 4 weeks)
- Abuse of alcohol or other drugs, smoker
- Cardiac failure, use of nitrates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.
Read the detailed description
INVESTIGATOR: Dr. Gabriela Riemekasten Anke Praast Prof. G. R. Burmester Prof. Falk Hiepe
OBJECTIVES:
Sildenafil is a very potent drug in the treatment of digital ulcers secondary to Raynaud´s phenomenon in patients with connective tissue diseases. Probably, sildenafil has a disease-modifying capability improving different signs of a disturbed regulation of vascular tone in connective tissue diseases. Sildenafil can be used over a long period without significant side effects in scleroderma patients and improves disease severity, life quality, and prognosis of patients with connective tissue diseases and secondary Raynaud's phenomenon.
SUBJECTS and CENTERS:
We want to study 10-15 patients with digital ulcers secondary to connective tissue diseases and which are refractory to other drugs, such as calcium channel blockers or iloprost. In this pilot study, patients are treated only in the Charité University Hospital.
INCLUSION/EXCLUSION CRITERIA
1 . Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon
- Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.
- Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
- No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy
EXCLUSION CRITERIA:
- Therapy with iloprost during the last 4 weeks
- Sympathectomy during the last 4 weeks
- TIA, stroke, myocardial infarction during the last 6 months
- Instable angina pectoris
- Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
- Microangiopathic hemolytic anaemia
- Azotaemia
- Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)
- Left ventricular ejection fraction< 20%
- Hypotonus < 80/40 mm Hg
- Positive pregnancy test
- History of cancer
- History of gastric/duodenic ulcers without endoscopic proof of complete healing
- Participation in other studies (currently or during the last 4 weeks)
- Abuse of alcohol or other drugs, smoker
- Cardiac failure, use of nitrates
STUDY DESIGN:
This is an open prospective pilot study of one centre determining the effect of a 6 month treatment of sildenafil in patients with acral ulcers in secondary Raynaud's phenomenon due to connective tissue diseases.
Drop out criteria's/ final points:
1 . Any change of the immunomodulating or suppressing therapy (e.g., treatment with cyclophosphamide because of an alveolitis; bolus of steroids > 30 mg/d).
- No response on the healing of ulcers after 4 weeks of treatment with sildenafil 3. Manifestation of new ulcers/necrosis under sildenafil 4. Escalation of medication with an vascular influence (calcium channel blockers, ACE inhibitors/AT II receptor blockers)
- Conditions
- Active Digital Ulcers
- Being tested
- Sildenafil therapy
- Keywords
- digital ulcers,, systemic sclerosis,, sildenafil,, vasoactive therapies
- Medical subject headings
- digital ulcers, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil therapyDrug
Also called start at 25 mg
oral use
| Study group | Role | What they receive |
|---|---|---|
| 1, active ulcers | Other | sildenafil treatment Receives: Drug: Sildenafil therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of digital ulcer
Measured: 6 months
Secondary outcomes (2)
Decrease of frequency/duration of Raynaud's attacks (monthly)
Measured: 6 months
Prevention of necroses manifestations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2004
- Primary completionNov 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Digital UlcersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Gabriela Riemekasten, MD, Principal investigator, Charité Universitätsklinik Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624273
- Sponsor's protocol ID
- SDN-D-002G
- Other IDs
- SDN-D-002G
- Acronym
- Sildenafil
- Status last verified
- Jul 2003
- First submitted
- 14 Feb 2008
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00624273
- Acronym / sponsor ID
- Sildenafil / SDN-D-002G
- Conditions
- Active Digital Ulcers
- Keywords
- digital ulcers,, systemic sclerosis,, sildenafil,, vasoactive therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 27 Feb 2008 (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.
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.
Detailed description
INVESTIGATOR: Dr. Gabriela Riemekasten Anke Praast Prof. G. R. Burmester Prof. Falk Hiepe
OBJECTIVES:
Sildenafil is a very potent drug in the treatment of digital ulcers secondary to Raynaud´s phenomenon in patients with connective tissue diseases. Probably, sildenafil has a disease-modifying capability improving different signs of a disturbed regulation of vascular tone in connective tissue diseases. Sildenafil can be used over a long period without significant side effects in scleroderma patients and improves disease severity, life quality, and prognosis of patients with connective tissue diseases and secondary Raynaud's phenomenon.
SUBJECTS and CENTERS:
We want to study 10-15 patients with digital ulcers secondary to connective tissue diseases and which are refractory to other drugs, such as calcium channel blockers or iloprost. In this pilot study, patients are treated only in the Charité University Hospital.
INCLUSION/EXCLUSION CRITERIA
1 . Digital gangrene, ulcers in patients with severe secondary Raynaud's phenomenon
- Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.
- Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
- No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy
EXCLUSION CRITERIA:
- Therapy with iloprost during the last 4 weeks
- Sympathectomy during the last 4 weeks
- TIA, stroke, myocardial infarction during the last 6 months
- Instable angina pectoris
- Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
- Microangiopathic hemolytic anaemia
- Azotaemia
- Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers)
- Left ventricular ejection fraction< 20%
- Hypotonus < 80/40 mm Hg
- Positive pregnancy test
- History of cancer
- History of gastric/duodenic ulcers without endoscopic proof of complete healing
- Participation in other studies (currently or during the last 4 weeks)
- Abuse of alcohol or other drugs, smoker
- Cardiac failure, use of nitrates
STUDY DESIGN:
This is an open prospective pilot study of one centre determining the effect of a 6 month treatment of sildenafil in patients with acral ulcers in secondary Raynaud's phenomenon due to connective tissue diseases.
Drop out criteria's/ final points:
1 . Any change of the immunomodulating or suppressing therapy (e.g., treatment with cyclophosphamide because of an alveolitis; bolus of steroids > 30 mg/d).
- No response on the healing of ulcers after 4 weeks of treatment with sildenafil 3. Manifestation of new ulcers/necrosis under sildenafil 4. Escalation of medication with an vascular influence (calcium channel blockers, ACE inhibitors/AT II receptor blockers)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, active ulcers | Other | Drug: Sildenafil therapysildenafil treatment |
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 gangrene, ulcers in patients with severe secondary Raynaud's phenomenon
- Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil.
- Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
- No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy
Key exclusion criteria (16 listed)
- Therapy with iloprost during the last 4 weeks
- Sympathectomy during the last 4 weeks
- TIA, stroke, myocardial infarction during the last 6 months
- Instable angina pectoris
- Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
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 |
|---|---|---|
| Sildenafil therapyAlso: start at 25 mgoral use | Drug | 1, active ulcers |
Primary outcome
healing of digital ulcer
Time frame: 6 months
2 secondary outcomes
Decrease of frequency/duration of Raynaud's attacks (monthly)
Time frame: 6 months
Prevention of necroses manifestations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2009.
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.
Dr. Gabriela Riemekasten, MD principal investigator
Charité Universitätsklinik Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil therapy in people with Active Digital Ulcers, run by Charite University, Berlin, Germany at 1 site in Germany.
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 16 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: finished, as of the sponsor's last update on 7 Jan 2009. 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 Germany. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of digital ulcer (time frame: 6 months). 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 7 Jan 2009.