Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-31 @ 12:41 AM
Study NCT ID:
NCT01472432
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2011-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D016523', 'term': 'Foot Ulcer'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raffaele.marfella@unina2.it', 'phone': '++390815665110', 'title': 'Dr Raffaele Marfella', 'organization': 'Second University Naples'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 years', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Full Epithelialization of the Wound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months.', 'groupDescription': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months of treatment with vildagliptin', 'description': 'Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.\n\nOptic microscopy is used to evaluate the epithelialization of the wound.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Capillary Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'classes': [{'title': '3 months data', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '90'}, {'value': '140', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '180'}]}]}, {'title': 'baseline data', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '80'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '88'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months', 'groupDescription': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '* Vildagliptin vs Placebo at 3 months.\n* Placebo baseline versus placebo 3 months.\n* Vildagliptin baseline versus Vildagliptin 3 months', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months of treatment with vildagliptin', 'description': 'Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.\n\nCapillary density is measured using immunohistochemistry', 'unitOfMeasure': 'capillaries/mm2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HIF-1α', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'classes': [{'title': '3 months data', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '400'}, {'value': '600', 'groupId': 'OG001', 'lowerLimit': '380', 'upperLimit': '800'}]}]}, {'title': 'Baseline data', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '350'}, {'value': '215', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '400'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\\< 0.05 versus control patients. P \\< 0.05 versus baseline.', 'groupDescription': 'p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VEGF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'classes': [{'title': '3 months data', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '500'}, {'value': '580', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '900'}]}]}, {'title': 'Baseline data', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '260'}, {'value': '215', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '280'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P\\< 0.05 versus control patients. P \\< 0.05 versus baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nPlacebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea'}], 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was not performed because an inadequate amount of biopsy tissue'}, {'type': 'SECONDARY', 'title': 'iNOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'OG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was not performed because an inadequate amount of biopsy tissue'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'FG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Ulcer Reduction', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Completed'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.\n\nplacebo: Placebo is added to the standard good medical practice.'}, {'id': 'BG001', 'title': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months\n\nvildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '14', 'groupId': 'BG000'}, {'value': '64', 'spread': '15', 'groupId': 'BG001'}, {'value': '64', 'spread': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The study group comprised 106 type 2 diabetic with chronic non-healing diabetic foot ulcers for more than 3 months duration. Patients were enrolled in the study between December 2008 and March 2011. Fifty-three diabetic patients were randomized (simple randomization, open labeled) to receive vildagliptin (50 mg b.i.d., n= 53) in addition to other concomitant hypoglycemic medication for 3 months.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-27', 'studyFirstSubmitDate': '2011-11-07', 'resultsFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-19', 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Full Epithelialization of the Wound', 'timeFrame': '3 months of treatment with vildagliptin', 'description': 'Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.\n\nOptic microscopy is used to evaluate the epithelialization of the wound.'}, {'measure': 'Capillary Density', 'timeFrame': '3 months of treatment with vildagliptin', 'description': 'Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.\n\nCapillary density is measured using immunohistochemistry'}], 'secondaryOutcomes': [{'measure': 'HIF-1α', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.'}, {'measure': 'VEGF', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.'}, {'measure': 'VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.'}, {'measure': 'iNOS', 'timeFrame': '3 months', 'description': 'The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'healing', 'foot ulcers', 'vildagliptin'], 'conditions': ['Chronic Foot Ulcers']}, 'referencesModule': {'references': [{'pmid': '23197976', 'type': 'RESULT', 'citation': 'Marfella R, Sasso FC, Rizzo MR, Paolisso P, Barbieri M, Padovano V, Carbonara O, Gualdiero P, Petronella P, Ferraraccio F, Petrella A, Canonico R, Campitiello F, Della Corte A, Paolisso G, Canonico S. Dipeptidyl peptidase 4 inhibition may facilitate healing of chronic foot ulcers in patients with type 2 diabetes. Exp Diabetes Res. 2012;2012:892706. doi: 10.1155/2012/892706. Epub 2012 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4 months of vildagliptin on healing of chronic ulcers in type 2 diabetes.', 'detailedDescription': 'The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in the developed world and is a major morbidity associated with diabetes, often leading to pain, suffering, and a poor quality of life for patients. Chronic diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes and precede 84% of all diabetes-related lower-leg amputations.The pathophysiology of chronic diabetic ulcers is complex and still incompletely understood, the most important predisposing factors being diabetic neuropathy and vasculopathy. Both micro and macroangiopathy strongly contribute to development and delayed healing of diabetic wounds, through an impaired tissue feeding and response to ischemia. HIF-1α and VEGF, as well as the NO production from iNOS, may contribute to limitation of hypoxic injury by promoting angiogenesis and wound healing. Experimental and pathological studies suggest that suggest that he incretin hormone glucagon-like peptide-1 (GLP-1) may improves VEGF generation, and promote pancreatic islet viability through the up-regulation of HIF1α.\n\nTherefore, aim of this study is to evaluate the effect of the augmentation of GLP-1, by inhibitors of the dipeptidyl peptidase IV (DPP-4), such as vildagliptin, on HIF-1α, VEGF and iNOS in diabetic chronic ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Oral hypoglycemic agents treatment\n* Chronic foot ulcers\n* Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test \\>30 -mmHg, anklebrachial index values \\> 0.7 and \\< 1.2 with toe pressure \\> 30 mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the affected leg\n* Written consensus\n\nExclusion Criteria:\n\n* Active Charcot disease\n* Ulcers resulting from electrical, chemical, or radiation burns\n* Collagen vascular disease\n* Ulcer malignancy\n* Untreated osteomyelitis, or cellulitis\n* Ulcer treatment with normothermic or hyperbaric oxygen therapy\n* Concomitant medications such as corticosteroids, immunosuppressive medications, or -chemotherapy\n* Recombinant or autologous growth factor products\n* Skin and dermal substitutes within 30 days of study start\n* Use of any enzymatic debridement treatments\n* Pregnant or nursing mothers'}, 'identificationModule': {'nctId': 'NCT01472432', 'briefTitle': 'DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Dipeptidyl Peptidase (DPP) IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IT 345461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for \\>3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'description': 'The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months', 'interventionNames': ['Drug: vildagliptin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea', 'armGroupLabels': ['Placebo']}, {'name': 'vildagliptin', 'type': 'DRUG', 'description': '50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea', 'armGroupLabels': ['Vildagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'I-80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'Second university of Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Raffaele Marfella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second University Naples'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Raffaele Marfella', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}