ClinicalTrials.gg
RecruitingNCT06969820HEALSPURUpdated Jul 31, 2026

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

An observational study in Calcaneal Spur, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by University of Erlangen-Nürnberg Medical School · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
40 Years and older
Sex
All
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Study 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

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Conditions studied

  • Calcaneal Spur

Browse trials for

03

In context

Heel Spur

32 studies on the registry are indexed under Heel Spur; 10 are open to participants now.

Browse Heel Spur studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Index >70%

Exclusion criteria

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 injections into the tendon prior to the study
  • Rheumatic or vascular diseases, lymphedema
  • Patients with tumors
  • Individuals of who do not use adequate 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureLow-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.

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What researchers measure

Primary outcomes

  1. Proof of clinical benefit of LDRT using pain scale

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

    Time frame: 36 months

  2. 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)

    Time frame: 36 months

  3. Proof of clinical benefit of LDRT using Calcaneodynia score

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

    Time frame: 36 months

  4. 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.

    Time frame: 36 months

  5. 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).

    Time frame: 36 months

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

07

Study locations

1 of 1 sites recruiting
  • Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
    Erlangen, Bavaria 91054, Germany
    Recruiting
    • Thomas PD Dr. med. Weissmann, MD · Contactthomas.weissmann@uk-erlangen.de · 09131/85-44209
    • Thomas PD Dr. med. Weissmann · Principal investigator
    • Florian PD Dr. med.Putz · Sub investigator
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
May 14, 2025
StartActual
Jun 1, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2028
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06969820
Responsible party
Sponsor
First posted
May 14, 2025
Start date
Jun 1, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jul 31, 2026

Study contacts

Thomas PD. Dr. med. Weissmann, MD
Contact
thomas.weissmann@uk-erlangen.de
+49913185 ext. 44209
Lisa Dr. rer. nat. Weissmann, PhD
Contact
lisa.weissmann@uk-erlangen.de
+49913185 ext. 44279

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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