Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Asses… (NCT06969820) | Clinical Trial Compass
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Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
Germany35 participantsStarted 2026-06-01
Plain-language summary
The clinical picture of calcaneal spur with plantar fasciitis is a debilitating disease that is difficult to treat with conservative and interventional measures. Radiotherapy has shown very good therapeutic results in retrospective data, which need to be clinically confirmed both subjectively and in terms of image morphology in a prospective approach.
Primary objective of the study:
To demonstrate a clinical benefit of LDRT: improvement of pain, functionality and quality of life after LDRT
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 39 years
* Typical clinical picture of plantar fasciitis for at least 3 months without associated trauma, other musculoskeletal co-morbidities or degenerative joint disease
* Patients with first-time application of LDRT to the affected joint
* Willingness to cooperate and accessibility of patients, especially geographical proximity, for treatment and follow-up
* Patients for whom LDRT is indicated independently of the study
* Karnofsky Index \>70%
Exclusion Criteria:
* Achillodynia ("dorsal" calcaneal spur)
* Previous trauma to the foot (fracture, tendon rupture)
* Musculoskeletal comorbidities of the foot
* Acute infections/open wounds in the area of the tendon to be examined or other relevant damage to the tendon to be examined
* Local steroid injections into the tendon prior to the study
* Rheumatic or vascular diseases, lymphedema
* Patients with tumors
* Individuals of childbearing potential who do not use adequate contraceptive measures consistently during therapy
* Persistent drug, medication or alcohol abuse
* Patients who have already undergone radiotherapy for the treatment of cancer
* Patients with an increased risk of an MRI examination, including the presence of metal implants, pacemakers or claustrophobia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proof of clinical benefit of LDRT using pain scale
Timeframe: 36 months
2
Proof of clinical benefit of LDRT using QoL
Timeframe: 36 months
3
Proof of clinical benefit of LDRT using Calcaneodynia score
Timeframe: 36 months
4
Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale
Timeframe: 36 months
5
Proof of clinical benefit of LDRT using Roles and Maudsley Scale
Timeframe: 36 months
Trial details
NCT IDNCT06969820
SponsorUniversity of Erlangen-Nürnberg Medical School