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RecruitingObservational

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

NCT ID: NCT04122313Sponsor: University of MinnesotaLast updated: 2026-03-19

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.

Arms & interventions

  • OtherEvaluation 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.

Outcome measures

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.

    Time frame: 2 years

Secondary

  • Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Diagnoses of Dupuytren's disease * English-speaking Exclusion Criteria: \- Patients with Dupuytren's disease who are not currently seeking treatment

Study locations (1)

University of Minnesota

Minneapolis, Minnesota, 55455

Recruiting
Leslie Chang · Contact
Post-contracture Release Radiation for Dupuytren's Disease | Cancerify