Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 6:16 PM
Study NCT ID:
NCT04927234
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2021-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foot and Ankle Post-operative Oedema Management Using Geko™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Standard block randomisation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of post-operative oedema formation using the figure-of-eight tape measurement', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery. This will be done using the figure of eight tape measurement method'}, {'measure': 'Assessment of post-operative oedema formation using the pitting oedema scale', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using the pitting oedema scale, where following a 2 second firm thumb press, 0 (min) indicates no oedema and 4 (max) is a very deep pit.'}, {'measure': 'Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using a bioimpedance device to measure resistance to electrical current in both legs and calculating the percentage difference between the operated leg and the contralateral limb.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events in each group', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery'}, {'measure': 'Incidence of device deficiencies', 'timeFrame': 'from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery', 'description': 'To assess the number of geko device deficiencies (if any)'}, {'measure': 'Change in pain level using a visual analogue scale (VAS) score', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible.'}, {'measure': 'Incidence of surgical wound healing', 'timeFrame': 'From surgery until up to 90 days post-surgery', 'description': 'Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.'}, {'measure': 'Change in analgesia dosage', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'Assessing changes in dosage of recorded analgesic medication taken by the patient'}, {'measure': 'Change in analgesia frequency', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'Assessing changes of frequency of recorded analgesic medication taken by the patient'}, {'measure': 'Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)', 'timeFrame': 'From pre-surgery assessment until up to 90 days post-surgery', 'description': 'Domains that are assessed in this questionnaire include walking/standing, pain and social interaction. Scores will range from 0 to 100, where 100 is most severe.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['geko', 'foot surgery', 'ankle surgery', 'oedema management', 'post-operative oedema'], 'conditions': ['Surgery', 'Edema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gekodevices.com/en-uk/', 'label': 'Device official website'}]}, 'descriptionModule': {'briefSummary': 'The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.', 'detailedDescription': 'The geko™ device has a wide range of clinical applications including the post-operative management of oedema.\n\nAlthough many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery.\n\nThis study is an open label, multi-centre prospective randomised study. The study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. These groups are defined as Group A patients who receive geko™ therapy and SC i.e. the intervention group and Group B patients who receive Standard Care (SC) only i.e. no intervention. The participants will be assessed pre-surgery and up to 90 days post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Intact healthy skin at the site of geko™ device application.\n* Patients that have been listed for forefoot and / or hindfoot surgery\n* Patient understands and is willing to participate in the study and can comply with study procedures\n* Patient is willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Pregnant\n* Use of any other neuro-modulation device.\n* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.\n* No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting\n* Participation in any other clinical study that may interfere with the outcome of either study'}, 'identificationModule': {'nctId': 'NCT04927234', 'briefTitle': 'Foot and Ankle Post-operative Oedema Management Using Geko™', 'organization': {'class': 'INDUSTRY', 'fullName': 'Firstkind Ltd'}, 'officialTitle': 'Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™', 'orgStudyIdInfo': {'id': 'FSK-F&A-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard of care + geko™ Therapy', 'description': 'In addition to their standard of care, for patients randomised to the intervention arm, geko™ therapy will be applied immediately post-surgery on the operated leg and administered for 24 hours / day whilst the patient remains in hospital, after which geko™ therapy will then be applied for 12hrs / day until the patient returns for their first post-operative follow-up visit (Day 14 ± 2 days post-surgery)', 'interventionNames': ['Device: geko™ therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Patients will receive their standard of care as per hospital practice.'}], 'interventions': [{'name': 'geko™ therapy', 'type': 'DEVICE', 'otherNames': ['geko', 'NMES'], 'description': 'Neuro-muscular electrical stimulation of the peroneal nerve', 'armGroupLabels': ['Standard of care + geko™ Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95010', 'city': 'Capitola', 'state': 'California', 'country': 'United States', 'facility': 'Golden State Orthopedics and Spine', 'geoPoint': {'lat': 36.97523, 'lon': -121.95329}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'TN2 4QJ', 'city': 'Royal Tunbridge Wells', 'country': 'United Kingdom', 'facility': 'Maidstone and Tunbridge Wells NHS Trust', 'geoPoint': {'lat': 51.13321, 'lon': 0.26256}}, {'zip': 'HA7 4LP', 'city': 'Stanmore', 'country': 'United Kingdom', 'facility': 'The Royal National Orthopaedic Hospital NHS Trust', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}], 'overallOfficials': [{'name': 'Shelain Patel, MB BS BSc(Hons) FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal National Orthopaedic Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firstkind Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}