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Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY

NCT01295736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-14

No results posted yet for this study

Summary

Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many patients and effective therapy remains elusive. In the present study, the investigators propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind control study in SSc patients.

Conditions

  • Systemic Scleroderma

Interventions

DRUG

Sildenafil

Sildenafil 20 mg TID per os during 90 days

DRUG

placebo

Placebo pills TID per os during 90 days

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Eric HACHULLA, PU-PH · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295736 on ClinicalTrials.gov