Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03583593
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'It is a double blind study, that is, neither the researcher nor the patient knows if he takes placebo or the active tablet.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of healing', 'timeFrame': '1 year', 'description': 'The most important outcome measure is to evaluate the early healing of diabetic foot ulcers with the shape and improvements of the foot ulcers.'}], 'secondaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '1 year', 'description': 'Glucose measures with blood test'}, {'measure': 'Lipidic control', 'timeFrame': '1 year', 'description': 'Triglycerides and cholesterol levels with blood test'}, {'measure': 'Body mass control', 'timeFrame': '1 year', 'description': 'Body mass test'}, {'measure': 'Renal function control', 'timeFrame': '1 year', 'description': 'Renal function measures by Creatinine Clearance Blood Test'}, {'measure': 'Insulin control', 'timeFrame': '1 year', 'description': 'Insulin levels measured by the Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Insulin', 'Diabetic Foot', 'Nutritional supplement', 'Diamel'], 'conditions': ['Diabetic Foot Ulcer', 'Diabetic Foot', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers. Method. Phase II clinical trial. A study group was created that receives the active product and another control group that receives a placebo. Double-blind study with a monthly follow-up for the first 6 months and then quarterly until the end of 1 year. Complementary tests are performed every 6 months to evaluate metabolic, lipid and renal function control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (% B) and insulin sensitivity (% S), as percentages of a normal reference population\n\nExclusion Criteria:\n\n* Manifestation of hypersensitivity to any component of the product\n* Uncooperative patients\n* Severe infection\n* Debilitating diseases\n* Steroid treatment\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03583593', 'briefTitle': 'Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Evaluation of Nutritional Supplement DIAMEL® Combined With Insulin in Diabetic Foot Ulcer', 'orgStudyIdInfo': {'id': 'DIAMEL-DIABETICFOOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIAMEL', 'description': 'Study group that receives the active product.', 'interventionNames': ['Dietary Supplement: DIAMEL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control group receiving double-blind placebo.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'DIAMEL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.', 'armGroupLabels': ['DIAMEL']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Vedado', 'state': 'La Habana', 'country': 'Cuba', 'facility': 'National Institute of Endocrinology', 'geoPoint': {'lat': 23.13767, 'lon': -82.39339}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}