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

NCT06969820 | Not Yet Recruiting

• 1 other identifier: 25-65-B
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Calcaneal Spur

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

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.

Treatment Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Heel Spur

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Thomas PD. Dr. med. Weissmann, MD

CONTACT

+49913185; thomas.weissmann@uk-erlangen.de

Lisa Dr. rer. nat. Deloch, PhD

CONTACT

+49913185; lisa.deloch@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 14, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 30, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)