Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 6:11 PM
Study NCT ID:
NCT01153633
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+41 58 258 55 47', 'title': 'Medical Scientific Affairs Manager', 'organization': 'B. Braun Medical AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Most likely the non-statistical significant results are due to the small sample size. No sample size calculation and statistical analysis was planned a priori because it was a pilot study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Celulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin maceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous ulcer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin chapped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change of Wound Size From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Irrigation Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 01.%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Inactive Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '-64.98', 'spread': '12.32', 'groupId': 'OG000'}, {'value': '-42.78', 'spread': '13.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2317', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'F-test (2-sided), ANCOVA with baseline target ulcer size as covariate', 'statisticalMethod': 'F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'percentage change in wound size (cm2)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set'}, {'type': 'SECONDARY', 'title': 'Number of Different Microganisms at V6/EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'unitOfMeasure': 'Number of microgasism species', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '26.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': "Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Condition of Wound Bed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '38.9', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '52.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS', 'unitOfMeasure': 'percentage of of wound bed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'PRIMARY', 'title': 'Healing of Target Ulcer atV6/EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4905', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Number of ulcers healed at V6/EOS', 'unitOfMeasure': 'ulcers', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'PRIMARY', 'title': 'Absolute Change of Target Ulcer From Baseline to Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide 0.1%, Betaine 0.1%, purified water, exipients'}, {'id': 'OG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.00', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9945', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'F-test (2-sided), ANCOVA with baseline target ulcer size as covariate', 'statisticalMethod': 'F-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'square centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide (0.1%), Betaine (0,1%), Purifed water'}, {'id': 'FG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Therapeutic failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prontosan Wound Solution and Gel', 'description': 'Polihexanide (0.1%), Betaine (0,1%), Purifed water'}, {'id': 'BG001', 'title': 'Normal Saline and Placebo Gel', 'description': 'Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '73.1', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '71.6', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of leg ulceration', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '360'}, {'value': '84', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '84'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '384'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2010-06-28', 'resultsFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-18', 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change of Wound Size From Baseline to Last Visit', 'timeFrame': '12 Weeks'}, {'measure': 'Healing of Target Ulcer atV6/EOS', 'timeFrame': '12 weeks', 'description': 'Number of ulcers healed at V6/EOS'}, {'measure': 'Absolute Change of Target Ulcer From Baseline to Last Visit', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Different Microganisms at V6/EoS', 'timeFrame': '12 Weeks'}, {'measure': 'Pain', 'timeFrame': '12 Weeks', 'description': "Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented 'no pain' and 100 mm 'worst possible pain'."}, {'measure': 'Condition of Wound Bed', 'timeFrame': '12 Weeks', 'description': 'Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and inactive gel by showing a reduction in size over a 12 week period.', 'detailedDescription': 'SUMMARY\n\nSponsor: B. BRAUN Medical AG\n\nTrade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel\n\nActive substance: Polihexanide (0.1%) Betaine (0.1%)\n\nStudy Duration (per patient):\n\n13 weeks, including the 1 week run in period\n\nPrimary Objective:\n\nTo evaluate the efficacy of the combination of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the reduction of wound size of hard-to-heal venous leg ulcers compared to control saline irrigation solution and inactive gel.\n\nSecondary Objectives:\n\nTo assess the change in bio-burden (assessment of organisms present) and to determine local tolerance as well as reduction in pain and to monitor exudate control.\n\nMethodology:\n\nA pilot randomised, double-blind, controlled clinical trial at a single centre\n\nPlanned number of patients:\n\nA sample size of N= 15 evaluable patients was estimated for each treatment group (group "A" and "B"). Adding a dropout rate of approx. 25% results in a total number of patients for both treatment groups of N=38.\n\nStudy Visits:\n\nVisit 0 (-1 week) - Screening Visit 1 ( Week 0) - Treatment and assessment visit Visit 2 (Week 1, day 7 +/- 1 day) - Treatment and assessment visit Visit 3 (Week 2, day14 +/- 1 day) - Treatment and assessment visit Visit 4 (Week 4, day 28 +/- 2 days) - Treatment and assessment visit Visit 5 (Week 8, day 56 +/- 2 days) - Treatment and assessment visit Visit 6 (Week 12, day 84 +/- 2 days) - End of study following 12 weeks of treatment or at healing whichever is soonest\n\nThe number of additional visits will be recorded in the Case Report Forms.\n\nTreatment efficacy assessment:\n\nClinical signs and symptoms will be compared between the two randomised groups with microbiological analysis and, computer planimetry assessments of ulcer size, using Visitrak™ (Smith \\& Nephew), and digital photography at entry to the study, at each planned study visit and at healing or 12 weeks, whichever is soonest.\n\nTolerance assessment:\n\nThe tolerability of study treatment will be evaluation based on the intensity and the course of adverse events (undesired concomitant effects, both subjectively perceived symptoms and objectively detected signs of disease). Tolerance assessments will take place from visit 2 onwards\n\nAssessment methods:\n\n1. Assessment of clinical signs and symptoms, in particular related to development of infection:\n\n * reduction of slough and necrotic tissue\n * control of exudate\n * presence of granulation tissue\n * reduction of inflammatory signs (surrounding skin)\n * pain\n2. Ulcer computerised planimetry using Visitrak™\n3. Microbiological analysis for bioburden (the bioburden within an ulcer relates to a microbiological qualitative and quantitative assessment of organisms present) assessed by wound swab or biopsy\n4. Serial photography with blinded assessment of progress using linear analogue scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged \\> 18 who are able to give informed consent\n* Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)\n* Venous leg ulcer present for ≥4 weeks\n* Surface area of the target ulcer ≥2cm2 and \\<100cm2 with the largest length not being \\>10cm\n* ABPI ≥ 0.7\n\nExclusion Criteria:\n\n* Age below 18 years\n* Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study\n* Pregnant or breast feeding women\n* Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics\n* Involvement in other trials within the past 1 month\n* Sensitivity to any of the components of Prontosan® or dressing material\n* Intolerance to compression therapy\n* Active osteomyelitis in the ulceration area\n* Active rheumatoid or collagen disease of blood vessels treated with corticosteroids\n* Chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)\n* Plasma protein below 4 g/dl\n* Anaemia: haemoglobin below 10 g/dl\n* Poorly controlled Diabetes (HBA1C \\> 12%)'}, 'identificationModule': {'nctId': 'NCT01153633', 'briefTitle': 'Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Ltd. Centre of Excellence Infection Control'}, 'officialTitle': 'Pilot, Randomised, Double-blind, Controlled Clinical Trial on the Combined Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel in the Reduction in Size and Change in Bioburden of Hard-to-heal Venous Leg Ulcers', 'orgStudyIdInfo': {'id': 'OPM-G-H 0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prontosan Wound Solution and Gel', 'description': 'Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)', 'interventionNames': ['Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline and Placebo Gel', 'description': 'Cleansing the wound bed, a sterile gauze dressing impregnated with the Prontosan® or saline solution, removed after 15 minutes; wound will be sparingly covered with Prontosan® Wound Gel or inactive gel. Secondary dressing to be a semi occlusive dressing. Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day)', 'interventionNames': ['Device: Normal Saline and Placebo Gel']}], 'interventions': [{'name': 'Prontosan Wound Irrigation Solution and Prontosan Wound Gel', 'type': 'DEVICE', 'description': 'The treatment procedures (after a 1 week run-in) include:\n\n* Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation\n* Secondary dressing to be a semi occlusive dressing\n* Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.', 'armGroupLabels': ['Prontosan Wound Solution and Gel']}, {'name': 'Normal Saline and Placebo Gel', 'type': 'DEVICE', 'description': 'The treatment procedures (after a 1 week run-in) include:\n\n* Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation\n* Secondary dressing to be a semi occlusive dressing\n* Secure the dressing to the wound with tubifast and short stretch compression system\n\nDressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.', 'armGroupLabels': ['Normal Saline and Placebo Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF14 4XN', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Cardiff University, Department of Wound Healing', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Keith Harding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff University, Department of Wound Healing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Ltd. Centre of Excellence Infection Control', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}