Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 2:01 AM
Study NCT ID:
NCT03384758
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by questionnaire', 'timeFrame': '12 Months', 'description': 'The Adverse Events are defined in the questionnaire as: Abort of the Therapy, Pressure marks, Quantification of the wearing comfort (Points 1-10), subjective reduction of the leg edema (Points 1-10)'}, {'measure': 'sO2', 'timeFrame': '12 Months', 'description': 'The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2'}, {'measure': 'Flow', 'timeFrame': '12 Months', 'description': 'The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow'}, {'measure': 'rHb', 'timeFrame': '12 Months', 'description': 'The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Compression therapy', 'Microcirculation', 'Diabetes mellitus', 'Peripheral Arterial Disease'], 'conditions': ['Peripheral Arterial Disease', 'Diabetes Mellitus', 'Leg Edema']}, 'referencesModule': {'references': [{'pmid': '32503811', 'type': 'DERIVED', 'citation': 'Rother U, Grussler A, Griesbach C, Almasi-Sperling V, Lang W, Meyer A. Safety of medical compression stockings in patients with diabetes mellitus or peripheral arterial disease. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001316. doi: 10.1136/bmjdrc-2020-001316.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.', 'detailedDescription': 'Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.\n\nTherefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy-Arm PAD:\n\n* leg edema\n* symptomatic PAD (Fontaine stage II)\n* no palpable foot pulses\n* ABI \\<0.9 and \\>0.6, absolute ankle pressure \\> 60mmHg\n\nStudy-Arm Diabetes:\n\n* leg edema\n* Diabetes mellitus Typ 2 (history of longer than 2 years)\n* palpable foot pulses\n* Pallaesthesie \\>6\n* Wagner Score 0\n\nExclusion Criteria:\n\nStudy-Arm PAD:\n\n* Critical limb ischemia\n* ABI \\< 0.6\n* simoultaneous Diabetes Mellitus\n\nStudy-Arm Diabetes:\n\n* Wagner Score \\>0\n* Pallasthesie \\<6'}, 'identificationModule': {'nctId': 'NCT03384758', 'briefTitle': 'Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Erlangen'}, 'officialTitle': 'Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'Perfusion under Compression'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mild to moderate PAD', 'interventionNames': ['Device: Compression Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetes mellitus', 'interventionNames': ['Device: Compression Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy volunteers', 'interventionNames': ['Device: Compression Therapy']}], 'interventions': [{'name': 'Compression Therapy', 'type': 'DEVICE', 'description': 'Therapy of the leg edema with compression stockings class I for three hours, after a short break with compression stocking class II for again three hours.', 'armGroupLabels': ['Diabetes mellitus', 'Healthy volunteers', 'mild to moderate PAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University of Erlangen, Vascular Surgery', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator PD Dr. med. Ulrich Rother', 'investigatorFullName': 'Ulrich Rother', 'investigatorAffiliation': 'University Hospital Erlangen'}}}}