Anti-Vasospasm: Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands

Sponsor

Christoph Hehrlein (Other)

Overall Status

Unknown status

CT.gov ID

NCT01378845

Collaborator

Actelion (Industry)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the prognostic influence of light rheography measurement at the fingertips from subjects with secundary Raynaud syndrome.

Condition or Disease	Intervention/Treatment	Phase
Raynaud's Phenomenon Skin Necrosis	Drug: Tracleer Drug: Prostavasin	N/A

Detailed Description

Digital Ulcers (DU) belong to one of the most prevalent complications of systemic scleroses, leading in course to considerable impairment in everyday and professional life. The aetiology of the emergence of DU in patients with systemic scleroses (SSc) is complex, whereas the disease itself is primarily characterized by a vasculopathy of the small arterial vessels. In the course of the disease this chronic infection leads to fibrotic intimal hyperplasia, adventitial fibrosis, and thus to a significant lumen narrowing. So far, a number of independent risk factors have been identified, such as male gender, chronic infections of the esophagus, pulmonary-arterial hypertension, evidence of specific antibodies (e.g. anti-Scl70) in the blood, or the a previous manifestation of a Raynoud Syndrom.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Monocenter, IIT, Open Controlled and Prospectiv Study to Define the Prognostic Influence of Light Rheography Measurement of Patients With Secundary Raynaud Syndrome With Ulcers at Fingertips Throughout the Medicinal Therapy

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Prostavasin	Drug: Prostavasin Prostavasin 60 µg i.v, 5 days per week for 2 weeks Other Names: Aprostadil
Active Comparator: Prostavasin + Bosentan	Drug: Tracleer 14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o Other Names: Bosentan Drug: Prostavasin Prostavasin 60 µg i.v, 5 days per week for 2 weeks Other Names: Aprostadil

Arm

Intervention/Treatment

Placebo Comparator: Prostavasin

Drug: Prostavasin

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Other Names:

Aprostadil

Active Comparator: Prostavasin + Bosentan

Drug: Tracleer

14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o

Other Names:

Bosentan

Drug: Prostavasin

Prostavasin 60 µg i.v, 5 days per week for 2 weeks

Other Names:

Aprostadil

Outcome Measures

Primary Outcome Measures

Quantification of the blood flow before, during and after the medical therapy [24 weeks]
The primary objective of this study is defined by the dynamics of the (post)capillary blood flow before (baseline value) and 12 weeks after treatment, measured by means of the LRR. In doing so, the therapeutic effect, in terms of the change in (post)capillary blood flow after treatment compared to baseline value, is to be quantitatively determined.

Secondary Outcome Measures

Emerge of new ulcers [> 24 weeks]
Additionally, it is to be examined if new DUs emerge after 24 weeks or not. The prospects for recovery of the DU will be investigated by means of visual analogue scale (VAS), photo-documentation, and D-LRR after 2, 6, 12, and 24 weeks of medicinal therapy. Furthermore, as mentioned above, the change in the HIF-1alpha gene expression before (baseline value) and 6 weeks after treatment is to be analyzed.