Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-29 @ 11:19 AM
Study NCT ID:
NCT01265004
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2010-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microcirculation', 'timeFrame': '6 month', 'description': 'The microcirculation is measured by O2c, an non-invalive device functioning with lightwaves. Based on this data the soft tissue damage, edema and healing process is protocoled.'}], 'secondaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '6 month', 'description': 'After 6 month the functinal outcome is measured by clinical scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Functional outcome'], 'conditions': ['Microcirculation', 'Achilles Tendon Rupture']}, 'descriptionModule': {'briefSummary': 'This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.', 'detailedDescription': 'This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.\n\nEvery method is long established and can be treated as clinical equal. So the surgical treatment is chosen randomly for each patient.\n\nFor this cause the microcirculation is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are nine measurements on this study: one before and one shortly after the surgery, followed by three measuring appointment every 6 hours (6,12,18,24 h post-op).Afterwards there are appointments planed after 12 days and 6 month. On the last appointment the patients are questioned according to established scores like AOFAS or VAS to register the functional outcome and level of pain.\n\nClinical parameters like time between rupture and surgical treatment, hospitalisation time, and form of anaesthesia are included to create comparable patient profiles. After 6 moths the last measurement appointment is stated, in which the clinical outcome is registered by Scores, e.g Mann-Whitney-Wilcoxon-Test.\n\nThis study is to detect any difference in wound heeling, re-rupture rate and functionality between these three methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute traumatic rupture of the achilles tendon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute rupture of the achilles tendon (on one or both sides)\n* Older than 18 year of age\n* Firmed letter of approval\n* Patient speaks/understands German\n* Planed surgical treatment\n* No more than 48h after rupture\n\nExclusion Criteria:\n\n* No-traumatic rupture of the achilles tendon\n* More than 48h after rupture\n* No planed surgical treatment\n* History of surgery on the injured leg\n* Condition of diabetes mellitus\n* Condition of peripheral artery occlusive disease'}, 'identificationModule': {'nctId': 'NCT01265004', 'acronym': 'MicroASR', 'briefTitle': 'Identification of Microcirculation After Surgical Treatment of Rupture of the Achilles Tendon', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Evaluation of Microcirculation in Skin and Tendon After Surgical Treatment of Acute Rupture of the Achilles Tendon With Stitches or Fibrin-glue', 'orgStudyIdInfo': {'id': 'CTC-A10-26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stitches, rupture of achilles tendon', 'description': 'Patients, in who the achilles tendon rupture was treated with tendon surgery including a special way of stitching to preserve the sliding ability of the tendon.', 'interventionNames': ['Procedure: Stitches']}, {'label': 'Fibrin-glue, rupture of achilles tendon', 'description': 'Patients, who received a surgical treatment including a fixing of the tendon with fibrin-glue.', 'interventionNames': ['Procedure: Fibrin-glue']}, {'label': 'Stiches and Fibrin-glue', 'description': 'Patients, in who the achilles rupture was treated with stitches and fibrin-glue.', 'interventionNames': ['Procedure: Stitches and Fibrin-glue']}], 'interventions': [{'name': 'Stitches', 'type': 'PROCEDURE', 'description': 'Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching', 'armGroupLabels': ['Stitches, rupture of achilles tendon']}, {'name': 'Fibrin-glue', 'type': 'PROCEDURE', 'description': 'Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue', 'armGroupLabels': ['Fibrin-glue, rupture of achilles tendon']}, {'name': 'Stitches and Fibrin-glue', 'type': 'PROCEDURE', 'description': 'Surgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue', 'armGroupLabels': ['Stiches and Fibrin-glue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universal Hospital of the RWTH Aachen University', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Hans-Christoph Pape, Univ-prof.MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chief of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}