A randomised multicentre, prospective, double blind phase III trial investigating the effect of radiotherapy on patients with Ledderhose disease.
- Conditions
- fibromatosis plantaris fascialisLedderhose10010761
- Registration Number
- NL-OMON50442
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
• Patients with painful Ledderhose disease. The pain score measured with the
VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst
imaginable pain).
• Age >= 18 years
• WHO performance status 0, 1 or 2
• Before patient randomisation, written informed consent must be given
according to ICH/GCP, and local regulations
• Able and willing to complete quality of life questionnaires in English or
Dutch
• Must be accessible for treatment follow-up
• Surgical intervention before for Ledderhose disease
• Previous radiation treatment for Ledderhose disease
• Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
• Not able to lay prone for at least fifteen minutes
• Females who are pregnant at entry or who want to become pregnant within six
months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method