Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04122313

Post-contracture Release Radiation for Dupuytren's Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dupuytren's Disease Connective Tissue Diseases Contracture Dupuytren Contracture Dupuytren Contracture of Left Palm Dupuytren Contracture of Right Palm Dupuytren Disease of Finger Dupuytren Disease of Palm and Finger Dupuytren's Contracture Left Dupuytren's Contracture Right Dupuytren's Disease of Palm of Left Hand Dupuytren's Disease of Palm of Right Hand Dupuytrens Contracture of Both Hands Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Leslie Chang

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnoses of Dupuytren's disease
  • English-speaking

Exclusion criteria

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

Treatment and study plan

Evaluation of Dupuytren's Disease Treatment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leslie Chang

CONTACT

[email protected]

612-273-6014

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Oct 10, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.