Status:
UNKNOWN
Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial
Lead Sponsor:
Masaryk Memorial Cancer Institute
Conditions:
Heel Spur
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the genera...
Detailed Description
Purpose/Objective The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of heel spurs (HSS, plantar fasciitis) through a prospective randomized open-label ...
Eligibility Criteria
Inclusion
- All patients referred to medical attention for non-malignant radiotherapy at the Department of Radiation oncology, Masaryk Memorial Cancer Institute (MMCI), will be screened for eligibility, and if all inclusion/exclusion criteria are met, they will be invited to participate in the present study.
- 1\) Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from a painful unilateral plantar heel spur for at least six months,
- 2\) indication to heel spur radiotherapy,
- 3\) 40 years or older patient, good performance status (Karnofsky index ≥ 70),
- 4\) exclusion of other local diseases by the orthopaedic surgeon,
- 5\) willingness of the patient to provide telephone or email contact to maintain follow up.
Exclusion
- 1\) Prior radiotherapy of heel spur (even if prior radiotherapy was performed on the contralateral heel spur because of possible bias given patient's expectations and experiences related to previous radiotherapy,
- 2\) corticosteroid local application during last 4 weeks prior to planned radiotherapy,
- 3\) rheumatic or vascular diseases, lymphatic edema of lower limb,
- 4\) former trauma or surgery of ipsilateral foot,
- 5\) any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risk for performance of radiotherapy including claustrophobia or jactation,
- 6\) any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements,
- 7\) pregnancy or breastfeeding,
- 8\) inability or unwillingness of subject to sign written informed consent.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06104410
Start Date
September 1 2022
End Date
December 31 2025
Last Update
October 31 2023
Active Locations (1)
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1
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53