Dupuytren's DiseaseNCT04122313
Post-contracture Release Radiation for Dupuytren's Disease
An observational study of Dupuytren's Disease and Dupuytren Contracture, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease, Dupuytren Contracture, Dupuytren Disease of Palm and Finger
- What is being tested?
- Evaluation of Dupuytren's Disease Treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: English-speaking adults with a diagnosis of Dupuytren's disease whose have chosen to follow the current treatment pathway.
Who may be able to join
- Diagnoses of Dupuytren's disease
- English-speaking
Who cannot join
- Patients with Dupuytren's disease who are not currently seeking treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Leslie Chang, dupuytrensumn@umn.edu
About this study
Official title: Efficacy of Post-contracture Release Radiation for the Treatment of 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.
Read the 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.
- Conditions
- 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
- Being tested
- Evaluation of Dupuytren's Disease Treatment
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Dupuytren's Disease TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Dupuytren's Contracture Disease | Patients with Dupuytren's Disease following the current treatment pathway Receives: Other: Evaluation of Dupuytren's Disease Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start31 May 2019
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Chang, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122313
- Sponsor's protocol ID
- ORTHOSURG-2018-26681
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT04122313
- Acronym / sponsor ID
- ORTHOSURG-2018-26681
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Dupuytren's Contracture Disease | – | Other: Evaluation of Dupuytren's Disease TreatmentPatients with Dupuytren's Disease following the current treatment pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- English-speaking adults with a diagnosis of Dupuytren's disease whose have chosen to follow the current treatment pathway.
Key inclusion criteria (2 listed)
- Diagnoses of Dupuytren's disease
- English-speaking
Key exclusion criteria (1 listed)
- Patients with Dupuytren's disease who are not currently seeking treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of Dupuytren's Disease TreatmentThere are no study interventions. The study interaction will be asking the patients to complete an additional outcome questionnaire and allow a medical record review. | Other | Patients with Dupuytren's Contracture Disease |
Primary outcome
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.
1 secondary outcome
Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Skin Involvement in Dupuytren Surgical Treatment Outcome
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Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leslie Chang principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease and Dupuytren Contracture, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Chang (612-273-6014, dupuytrensumn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Southampton Dupuytren's Scoring System (SDSS) Questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.