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NCT04122313 | RECRUITING | Dupuytren's Disease


Post-contracture Release Radiation for Dupuytren's Disease
Sponsor:

The 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.

Condition or disease

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

Dupuytren's Disease of Palm of Left Hand

Dupuytren Contracture of Right Palm

Dupuytren Contracture of Left Palm

Dupuytren's Contracture Left

Dupuytren's Contracture Right

Intervention/treatment

Evaluation of Dupuytren's Disease Treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
Actual Study Start Date : 2019-05-31
Estimated Primary Completion Date : 2026-03-01
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnoses of Dupuytren's disease
  • * English-speaking
Exclusion Criteria
  • - Patients with Dupuytren's disease who are not currently seeking treatment

Post-contracture Release Radiation for Dupuytren's Disease

Location Details

NCT04122313


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How to Participate

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Locations


RECRUITING

United States, Minnesota

The University of Minnesota

Minneapolis, Minnesota, United States, 55455

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