Overview

This trial is active, not recruiting.

Conditions dupuytren contracture, disease progression
Sponsor University Medical Centre Groningen
Start date May 2012
End date July 2017
Trial size 230 participants
Trial identifier NCT01923103, NDPDD

Summary

Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.

The aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
The natural course of progression of DD; change in severity of disease from baseline to measurement point
time frame: every 3-6 months depending on severity of disease, with a maximum of 5 years

Secondary Outcomes

Measure
Risk factors and their change over time
time frame: every 3-6 months, depending on the severity of disease with a maximum of 5 years
change in hand function
time frame: every 3-6 months depending on disease severity, with a maximum of 5 years
Occurence of recurrent disease
time frame: every 3-6 months, depending on primary disease severity with a maximum of 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients (> 18 years of age) with primary Dupuytren's disease in all Tubiana stages - Operated hands of patients with primary Dupuytren's disease on the contra lateral hand Exclusion Criteria: - Patients who are incapable of giving consent - Patients who are not able or not willing to visit the UMCG for follow-up - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Additional Information

Official title Natural Disease Progress of Dupuytren Disease
Description Objective: - Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age. - Secondary objectives: 1. To study the effect of potential risk factors for DD on natural disease progress. 2. To study at what stage of disease patients with DD experience problems in daily life. 3. To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time. - Study design: The study is designed as a prospective observational pilot study with a maximum follow-up of five years. - Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease - Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint. - Secondary study parameters: Michigan Hand Outcomes Questionnaire (MHOQ) and Patient-Rated Wrist/Hand Evaluation (PRWHE)to measure hand function.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University Medical Centre Groningen.