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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04122313
Other study ID # ORTHOSURG-2018-26681
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2019
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source University of Minnesota
Contact Kathryn Dusenbery
Phone 612-273-6014
Email dupuytrensumn@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.


Description:

This is an observational, pilot study. Participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, PNA and CCH injection, followed by post-operative radiation. All enrolled participants will undergo radiation treatment as soon as possible following contracture release. Radiotherapy will consist of 5 daily treatments of 300 cGy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cGy, for a total of 3000 cGy in 10 total fractions. This dosing schedule is commonly used in the published literature. The data to be collected about participants, is their Southampton Dupuytren's score, history and clinical symptoms and photographs of their hand. This information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnoses of Dupuytren's disease - English-speaking Exclusion Criteria: - Patients with Dupuytren's disease who are not currently seeking treatment

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Southampton Dupuytren's Scoring System (SDSS) Questionnaire 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. 2 years
Secondary Common Terminology Criteria for Adverse Events (CTCAE) 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. 2 years
See also
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