Calcaneal SpurHEALSPURNCT06969820
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 of Calcaneal Spur, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Calcaneal Spur
- What is being tested?
- Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2026to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.
Who may be able to join
- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Erlangen, Bavaria, 91054
Thomas PD Dr. med. Weissmann, MD, 09131/85-44209, thomas.weissmann@uk-erlangen.de
Thomas PD Dr. med. Weissmann
About this study
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
- Being tested
- Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniquesProcedure or surgery
LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of clinical benefit of LDRT using pain scale
Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)
Measured: 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)
Measured: 36 months
Proof of clinical benefit of LDRT using Calcaneodynia score
Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)
Measured: 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.
Measured: 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).
Measured: 36 months
Secondary outcomes (4)
Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol
Measured: 36 months
Correlation of subjective pain parameters with laboratory chemical examinations.
Measured: 36 months
Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.
Measured: 36 months
Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneal SpurStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969820
- Sponsor's protocol ID
- 25-65-B
- Acronym
- HEALSPUR
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06969820
- Acronym / sponsor ID
- HEALSPUR / 25-65-B
- Conditions
- Calcaneal Spur
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Procedure: Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniquesRadiotherapy 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniquesLDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase. | Procedure or surgery | Treatment Group |
Primary outcome
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)
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)
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)
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.
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).
4 secondary outcomes
Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol
Time frame: 36 months
Correlation of subjective pain parameters with laboratory chemical examinations.
Time frame: 36 months
Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.
Time frame: 36 months
Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcaneal Spur, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas PD. Dr. med. Weissmann, MD (+49913185 ext. 44209, thomas.weissmann@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof of clinical benefit of LDRT using pain scale (time frame: 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.