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

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

Study Overview

• Status: Recruiting
• Conditions: Calcaneal Spur
• Intervention / Treatment: Procedure: Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Thomas PD. Dr. med. Weissmann, MD; Phone Number: 44209 +49913185; Email: thomas.weissmann@uk-erlangen.de
• Study Contact Backup: Name: Lisa Dr. rer. nat. Weissmann, PhD; Phone Number: 44279 +49913185; Email: lisa.weissmann@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
      • Contact: Thomas PD Dr. med. Weissmann, MD; Phone Number: 09131/85-44209; Email: thomas.weissmann@uk-erlangen.de
      • Principal Investigator: Thomas PD Dr. med. Weissmann
      • Sub-Investigator: Florian PD Dr. med.Putz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Radiotherapy with a guideline-compliant (Radiotherapy of benign diseases; specialist group-specific evidence-based S2e guideline of the German Society for Radio-Oncology (DEGRO)) single dose of 0.5 Gy (3.0 Gy total dose) over 3 weeks and, if pain persists, a second series with the same dosage at 12-week intervals.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proof of clinical benefit of LDRT using pain scale	Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)	36 months
Proof of clinical benefit of LDRT using QoL	QoL: SF-8 (Short Form-8 Health Survey), scale from 0-100 (0..worst score - 100..best score)	36 months
Proof of clinical benefit of LDRT using Calcaneodynia score	Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)	36 months
Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale	AOFAS Hindfoot Scale, Score ranges from 0 to 100, with healthy ankles receiving 100 points.	36 months
Proof of clinical benefit of LDRT using Roles and Maudsley Scale	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).	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol	36 months
Correlation of subjective pain parameters with laboratory chemical examinations.	36 months
Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.	36 months
Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.	36 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: May 13, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Heel Spur; Therapeutics; Radiotherapy
• Other Study ID Numbers: 25-65-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No