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Recruiting NCT06969820

Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis

— Observational Calcaneal Spur

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques.
Who it may be relevant to
Registry conditions: Calcaneal Spur. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Procedure Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques
    LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.

Primary outcome measures

  • Proof of clinical benefit of LDRT using pain scale [Time frame: 36 months]
  • Proof of clinical benefit of LDRT using QoL [Time frame: 36 months]
  • Proof of clinical benefit of LDRT using Calcaneodynia score [Time frame: 36 months]
  • Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale [Time frame: 36 months]
  • Proof of clinical benefit of LDRT using Roles and Maudsley Scale [Time frame: 36 months]
Secondary outcome measures (4)
  • Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol [Time frame: 36 months]
  • Correlation of subjective pain parameters with laboratory chemical examinations. [Time frame: 36 months]
  • Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum. [Time frame: 36 months]
  • Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings. [Time frame: 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlange — Erlangen

Identifiers

NCT: NCT06969820 · 25-65-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗