Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-11 @ 11:51 AM
Study NCT ID:
NCT04117269
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2019-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of diabetic foot ulcers healed', 'timeFrame': '12 weeks', 'description': 'Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate'}], 'secondaryOutcomes': [{'measure': 'Percentage of diabetic foot ulcers healed', 'timeFrame': '20 weeks', 'description': 'Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate'}, {'measure': 'Adherence to offloading device', 'timeFrame': '3 days', 'description': 'Two pedometer will be used (one inside the vendaje and the other into the offloading device)'}, {'measure': 'Time to healing', 'timeFrame': '30 weeks', 'description': 'Time in weeks of diabetic foot ulcer healing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer', 'Peripheral Neuropathy', 'Treatment Adherence and Compliance']}, 'descriptionModule': {'briefSummary': 'Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plantar diabetic foot ulcer.\n* Wagner I and II classification.\n* Ulcer area between 1-30 cm square centimeters.\n* HbA1c values in the last three months below 11%\n* Ankle brachial Index (ABI) value \\> 0.5.\n\nExclusion Criteria:\n\n* Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.\n* Presence of foot ulcer in both feet.\n* Presence of soft tissue infection.\n* Osteomyelitis suspicion.\n* Peripheral neuropathy due to different causes than diabetes.'}, 'identificationModule': {'nctId': 'NCT04117269', 'briefTitle': 'External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': '19/337-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External shoe lift', 'description': 'Those patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer).', 'interventionNames': ['Device: External shoe lift']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.'}], 'interventions': [{'name': 'External shoe lift', 'type': 'DEVICE', 'description': 'Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously', 'armGroupLabels': ['External shoe lift']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raúl Juan Molines Barroso, Phd', 'role': 'CONTACT', 'email': 'rauljmolines@hotmail.com', 'phone': '639059104', 'phoneExt': '+34'}, {'name': 'José Luis Lázaro Martínez, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marta García-Madrid Martín de Almagro, Phd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mateo López Moral, Phd', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Diabetic foot Unit Complutense University', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Raúl Juan Molines Barroso, Phd', 'role': 'CONTACT', 'email': 'rauljmolines@hotmail.com', 'phone': '639059104', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Raúl Juan Molines Barroso, Phd', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}