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

NCT ID: NCT06969820

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Erlangen, Bavaria, Germany

Countries

Germany

Central Contacts

Thomas PD. Dr. med. Weissmann, MD

Role: CONTACT

thomas.weissmann@uk-erlangen.de

+49913185 ext. 44209

Lisa Dr. rer. nat. Deloch, PhD

Role: CONTACT

lisa.deloch@uk-erlangen.de

+49913185 ext. 44279

Facility Contacts

Thomas PD Dr. med. Weissmann, MD

Role: primary

thomas.weissmann@uk-erlangen.de

09131/85-44209

Other Identifiers

25-65-B

Identifier Type: -

Identifier Source: org_study_id