Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06969820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036982', 'term': 'Heel Spur'}], 'ancestors': [{'id': 'D005096', 'term': 'Exostoses'}, {'id': 'D015576', 'term': 'Hyperostosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proof of clinical benefit of LDRT using pain scale', 'timeFrame': '36 months', 'description': 'Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)'}, {'measure': 'Proof of clinical benefit of LDRT using QoL', 'timeFrame': '36 months', 'description': 'QoL: SF-8 (Short Form-8 Health Survey), scale from 0-100 (0..worst score - 100..best score)'}, {'measure': 'Proof of clinical benefit of LDRT using Calcaneodynia score', 'timeFrame': '36 months', 'description': 'Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)'}, {'measure': 'Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale', 'timeFrame': '36 months', 'description': 'AOFAS Hindfoot Scale, Score ranges from 0 to 100, with healthy ankles receiving 100 points.'}, {'measure': 'Proof of clinical benefit of LDRT using Roles and Maudsley Scale', 'timeFrame': '36 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol', 'timeFrame': '36 months'}, {'measure': 'Correlation of subjective pain parameters with laboratory chemical examinations.', 'timeFrame': '36 months'}, {'measure': 'Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.', 'timeFrame': '36 months'}, {'measure': 'Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.', 'timeFrame': '36 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcaneal Spur']}, 'descriptionModule': {'briefSummary': '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.\n\nPrimary objective of the study:\n\nTo demonstrate a clinical benefit of LDRT: improvement of pain, functionality and quality of life after LDRT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 39 years\n* Typical clinical picture of plantar fasciitis for at least 3 months without associated trauma, other musculoskeletal co-morbidities or degenerative joint disease\n* Patients with first-time application of LDRT to the affected joint\n* Willingness to cooperate and accessibility of patients, especially geographical proximity, for treatment and follow-up\n* Patients for whom LDRT is indicated independently of the study\n* Karnofsky Index \\>70%\n\nExclusion Criteria:\n\n* Achillodynia ("dorsal" calcaneal spur)\n* Previous trauma to the foot (fracture, tendon rupture)\n* Musculoskeletal comorbidities of the foot\n* Acute infections/open wounds in the area of the tendon to be examined or other relevant damage to the tendon to be examined\n* Local steroid injections into the tendon prior to the study\n* Rheumatic or vascular diseases, lymphedema\n* Patients with tumors\n* Individuals of childbearing potential who do not use adequate contraceptive measures consistently during therapy\n* Persistent drug, medication or alcohol abuse\n* Patients who have already undergone radiotherapy for the treatment of cancer\n* Patients with an increased risk of an MRI examination, including the presence of metal implants, pacemakers or claustrophobia'}, 'identificationModule': {'nctId': 'NCT06969820', 'acronym': 'HEALSPUR', 'briefTitle': 'Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis', 'orgStudyIdInfo': {'id': '25-65-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': '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.', 'interventionNames': ['Procedure: Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques']}], 'interventions': [{'name': 'Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques', 'type': 'PROCEDURE', 'description': 'LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'contacts': [{'name': 'Thomas PD Dr. med. Weissmann, MD', 'role': 'CONTACT', 'email': 'thomas.weissmann@uk-erlangen.de', 'phone': '09131/85-44209'}, {'name': 'Thomas PD Dr. med. Weissmann', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Florian PD Dr. med.Putz', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Thomas PD. Dr. med. Weissmann, MD', 'role': 'CONTACT', 'email': 'thomas.weissmann@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '44209'}, {'name': 'Lisa Dr. rer. nat. Deloch, PhD', 'role': 'CONTACT', 'email': 'lisa.deloch@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '44279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}