Post-contracture Release Radiation for Dupuytren's Disease

Recruiting

• Conditions: Dupuytren Disease of Palm and Finger; Dupuytren's Contracture Right; Dupuytren Disease of Finger; Dupuytren Contracture of Right Palm; Dupuytren's Disease; Dupuytren Contracture; Dupuytrens Contracture of Both Hands; Dupuytren's Disease of Palm of Right Hand; Dupuytren's Disease of Palm of Left Hand; Dupuytren Contracture of Left Palm
• Interventions: Other: Evaluation of Dupuytren's Disease Treatment

• Registration Number: NCT04122313
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-05-31
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnoses of Dupuytren's disease
• English-speaking

Read More

Exclusion Criteria

• Patients with Dupuytren's disease who are not currently seeking treatment

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Dupuytren's Contracture Disease	Evaluation of Dupuytren's Disease Treatment	Patients with Dupuytren's Disease following the current treatment pathway

Primary Outcome Measures

Name	Time	Method
Southampton Dupuytren's Scoring System (SDSS) Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Common Terminology Criteria for Adverse Events (CTCAE)	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States