Post-contracture Release Radiation for Dupuytren's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04122313|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment|
|Dupuytren's Disease Dupuytren Contracture Dupuytren Disease of Palm and Finger Dupuytren Disease of Finger Dupuytrens Contracture of Both Hands Dupuytren's Disease of Palm of Right Hand Dupuytren's Disease of Palm of Left Hand Dupuytren Contracture of Right Palm Dupuytren Contracture of Left Palm Dupuytren's Contracture Left Dupuytren's Contracture Right||Other: Evaluation of Dupuytren's Disease Treatment|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease|
|Actual Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2023|
Patients with Dupuytren's Contracture Disease
Patients with Dupuytren's Disease following the current treatment pathway
Other: Evaluation of Dupuytren's Disease Treatment
There are no study interventions. The study interaction will be asking the patients to complete an additional outcome questionnaire and allow a medical record review.
- Southampton Dupuytren's Scoring System (SDSS) Questionnaire [ Time Frame: 2 years ]The primary study endpoint is the patient's self-reported function which will be assessed using the validated Southampton Dupuytren's Scoring System (SDSS) questionnaire. The SDSS is a 5 item questionnaire with item scores ranging from 0 (no problem) to 4 (severe problem). Total scores are a sum of the 5 item scores with a total score range of 0 to 20. High scores indicate greater impairment due to the disease.
- Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 2 years ]The secondary endpoint will be the recurrence rate (which is defined as an increase in joint contracture on any treated joint of at least 20 degrees at one year post-treatment compared to six weeks post treatment) and skin toxicity, which will be assessed by CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122313
|Contact: Kathryn Dusenbery, MDemail@example.com|
|Contact: Kate Bak, MSfirstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Kathryn Dusenbery, MD 612-626-6146 email@example.com|
|Contact: Kate Bak, MS 612-626-5403 firstname.lastname@example.org|