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临床试验/NCT04122313
NCT04122313招募中不适用

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Southampton Dupuytren's Scoring System (SDSS) Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnoses of Dupuytren's disease
  • English-speaking

排除标准

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

结局指标

主要结局

Southampton Dupuytren's Scoring System (SDSS) Questionnaire

时间窗: 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.

次要结局

  • Common Terminology Criteria for Adverse Events (CTCAE)(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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