Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-27 @ 12:54 PM
Study NCT ID:
NCT06786403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Bromelain Supplement 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001963', 'term': 'Bromelains'}], 'ancestors': [{'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010450', 'term': 'Endopeptidases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound surface area', 'timeFrame': 'At baseline and every 2 weeks until the end of treatment at 8 weeks', 'description': 'Dimensions (length and width) by Image J'}], 'secondaryOutcomes': [{'measure': 'The amount of pain', 'timeFrame': 'At baseline and every 2 weeks until the end of treatment at 8 weeks', 'description': 'By Visual Analogue Scale (VAS)'}, {'measure': 'The amount of inflammation', 'timeFrame': 'At baseline and every 4 weeks until the end of treatment at 8 weeks', 'description': 'Lab test parameters of ESR \\& CRP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot ulcer', 'bromelain'], 'conditions': ['Diabetic Foot Ulcer (DFU)']}, 'descriptionModule': {'briefSummary': 'This study will be conducted on people over 18 with diabetic foot ulcers.. The first group will receive the standard treatment along with bromelain supplement and the second group will receive the standard treatment and placebo. The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process. Wound surface area, rate of pain, rate of inflammatory factors (ESR and CRP) will be assessed at baseline and every two weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Patients diagnosed with diabetic foot ulcers of category 0, 1 and 2 according to the Wagner criteria\n* Patients aware of the study process for monitoring after filling out the informed consent form\n\nExclusion Criteria:\n\n* People who are allergic to pineapple, celery, carrot and fennel\n* Pregnant and lactating women\n* Severe kidney failure (GFR\\<30)\n* Severe liver failure (Child Pugh B, C)\n* Patients with hemophilia\n* People taking anticoagulant drugs, anti-platelet and thrombolytic\n* Patients with irregular heartbeat and tachycardia\n* Patients with asthma'}, 'identificationModule': {'nctId': 'NCT06786403', 'briefTitle': 'The Effects of Bromelain Supplement in Patients with Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'Investigating the Effectiveness of the Supplement Containing Enteric-coated Bromelain (Anaheal 1200 GDU) in Healing Wounds, Pain, and Inflammation in Patients Over 18 Years Old with Diabetic Foot Ulcers Compared to Placebo', 'orgStudyIdInfo': {'id': '162948239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enteric-coated bromelain', 'description': 'Intervention : Bromelain', 'interventionNames': ['Dietary Supplement: Bromelain']}], 'interventions': [{'name': 'Bromelain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary Supplement: Bromelain 1000 mg/day', 'armGroupLabels': ['enteric-coated bromelain']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (1000 mg/day)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19835', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'contacts': [{'name': 'Azita Hekmatdoost, MD, PhD', 'role': 'CONTACT', 'email': 'a_hekmat2000@yahoo.com', 'phone': '+989123065084'}, {'name': 'Mobina Tajdari, PharmD student', 'role': 'CONTACT', 'email': 'mobinatjdr@gmail.com', 'phone': '+989100037364'}], 'facility': 'Iran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Azita Hekmatdoost, MD, PhD', 'role': 'CONTACT', 'email': 'a_hekmat2000@yahoo.com', 'phone': '+989123065084'}, {'name': 'Amir Rezazadeh, PharmD, BCPS', 'role': 'CONTACT', 'email': 'Rezazadeh.am@iums.ac.ir', 'phone': '+989127298761'}], 'overallOfficials': [{'name': 'Mobina Tajdari, PharmD Student', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kamyab Andarzbakhsh, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Azita Hekmatdoost', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}