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NCT Number: NCT06969820

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

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

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Key information

Conditions

Calcaneal Spur Bone Diseases Exostoses Foot Diseases Heel Spur Hyperostosis Musculoskeletal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques

Procedure

LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.

Primary outcomes

  1. Proof of clinical benefit of LDRT using pain scale

    Time frame: 36 months

    Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)

  2. Proof of clinical benefit of LDRT using QoL

    Time frame: 36 months

    QoL: SF-8 (Short Form-8 Health Survey), scale from 0-100 (0..worst score - 100..best score)

  3. Proof of clinical benefit of LDRT using Calcaneodynia score

    Time frame: 36 months

    Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)

  4. Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale

    Time frame: 36 months

    AOFAS Hindfoot Scale, Score ranges from 0 to 100, with healthy ankles receiving 100 points.

  5. Proof of clinical benefit of LDRT using Roles and Maudsley Scale

    Time frame: 36 months

    Roles and Maudsley scale is a 4-point subjective assessment used to evaluate patient pain and limitations in daily activities following treatment. It ranges from 1 (excellent result, no symptoms) to 4 (poor result, symptoms identical or worse than before treatment).

Secondary outcomes

  1. Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol

    Time frame: 36 months

  2. Correlation of subjective pain parameters with laboratory chemical examinations.

    Time frame: 36 months

  3. Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.

    Time frame: 36 months

  4. Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.

    Time frame: 36 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: HEALSPUR

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 14, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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