NCT04229147

Brief Summary

The aim of the LedRad LTE study is to determine the current complaints, late side effects and satisfaction of patients who were treated with radiotherapy for Ledderhose disease at least two years ago.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

July 5, 2019

Last Update Submit

February 26, 2024

Conditions

Ledderhose Disease

Keywords

RadiotherapyPainSide effectSatisfaction

Outcome Measures

Primary Outcomes (1)

  • Current pain

    Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain

    at least 2 years after treatment

Secondary Outcomes (4)

  • Worst pain

    at least 2 years after treatment

  • Quality of Life

    at least 2 years after treatment

  • Late side effects of treatment

    at least 2 years after treatment

  • Satisfaction with radiotherapy treatment for Ledderhose disease

    at least 2 years after treatment

Interventions

RadiotherapyRADIATION

Patients who received a total dose of 30 Gy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Ledderhose disease and treated with radiotherapy at least 2 years ago at the UMCG

Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Fibromatosis, PlantarPainPersonal Satisfaction

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsFoot DiseasesMusculoskeletal DiseasesContractureMuscular DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

January 18, 2020

Study Start

May 13, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)