Health TrialsbyHealthPanel

Post-contracture Release Radiation for Dupuytren's Disease

ConditionsDupuytren's DiseaseDupuytren ContractureDupuytren Disease of Palm and FingerDupuytren Disease of FingerDupuytrens Contracture of Both HandsDupuytren's Disease of Palm of Right HandDupuytren's Disease of Palm of Left HandDupuytren Contracture of Right PalmDupuytren Contracture of Left PalmDupuytren's Contracture LeftDupuytren's Contracture Right
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnoses of Dupuytren's disease

English-speaking

Disqualifiers

None

Trial population

English-speaking adults with a diagnosis of Dupuytren's disease whose have chosen to follow the current treatment pathway.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Evaluation of Dupuytren's Disease Treatment

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients with Dupuytren's Contracture Disease1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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