Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT04461132
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Manual Lymphatic Drainage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}], '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'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}, {'id': 'D017592', 'term': 'Skin Care'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006920', 'term': 'Hygiene'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of wound healing', 'timeFrame': 'Change from baseline wound healing following the end of treatment (12. treatment session) and 1 month after the end of treatment.', 'description': 'Wound was assesed by analyzing photographes of wound with Tracker software.'}, {'measure': 'Evaluation of range of motion of ankle', 'timeFrame': 'Change from baseline range of motion following the end of treatment (12. treatment session) and 1 month after the end of treatment.', 'description': 'range of motion of ankle was measured with goniometer'}, {'measure': 'Evaluation of pain', 'timeFrame': 'Change from baseline pain following the end of treatment (12. treatment session) and 1 month after the end of treatment.', 'description': 'Pain was evaluated by Visual Analog Scale between 0 (no pain)-10 (extreme) pain.'}, {'measure': 'evaluation of edema', 'timeFrame': 'Change from baseline edema following the end of treatment (12. treatment session) and 1 month after the end of treatment.', 'description': 'edema was measured by 3D scanner'}, {'measure': 'evaluation of quality of life', 'timeFrame': 'Change from baseline quality of life following scores the end of treatment (12. treatment session) and 1 month after the end of treatment.', 'description': 'quality of life was evaluated by SF- 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Leg Ulcer', 'Venous Insufficiency', 'Lymphatic Disease']}, 'referencesModule': {'references': [{'pmid': '21337794', 'type': 'RESULT', 'citation': 'Azoubel R, Torres Gde V, da Silva LW, Gomes FV, dos Reis LA. [Effects of the decongestive physiotherapy in the healing of venous ulcers]. Rev Esc Enferm USP. 2010 Dec;44(4):1085-92. doi: 10.1590/s0080-62342010000400033. Portuguese.'}, {'pmid': '28624002', 'type': 'RESULT', 'citation': 'Crawford JM, Lal BK, Duran WN, Pappas PJ. Pathophysiology of venous ulceration. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):596-605. doi: 10.1016/j.jvsv.2017.03.015.'}, {'pmid': '27707417', 'type': 'RESULT', 'citation': "de Roos KP, Wittens CH, Maessen-Visch MB, van der Wegen-Franken CP. [Universal Dutch guideline on 'Venous disease']. Ned Tijdschr Geneeskd. 2014;158(0):A8076. Dutch."}, {'pmid': '20559172', 'type': 'RESULT', 'citation': 'Williams A. Manual lymphatic drainage: exploring the history and evidence base. Br J Community Nurs. 2010 Apr;15(4):S18-24. doi: 10.12968/bjcn.2010.15.Sup3.47365.'}, {'pmid': '26025146', 'type': 'RESULT', 'citation': 'Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.'}, {'pmid': '16835515', 'type': 'RESULT', 'citation': 'Hampton S. An introduction to various types of leg ulcers and their management. Br J Nurs. 2006 Jun 8-21;15(11):S9-13. doi: 10.12968/bjon.2006.15.Sup2.21235.'}]}, 'descriptionModule': {'briefSummary': 'In venous ulcer, venous insufficiency is accompanied by lymphatic insufficiency. Manual lymphatic drainage (mld) technique cause to increase contraction rate of lymphatic collector and venous flow. It is known that Manual lymphatic drainage accelerates microcirculation, enabling nutrients and oxygen to reach tissues and at the same time removing residual substances from the tissue. We hypothesis that if we inrease to lypmhatic activity with MLD, we could stimulate healing of ulcer. The aim of this study to investigate the effect of manual lymphatic drainage on venous ulcer healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with venous ulcer unhealing for at least 6 weeks\n* Without enfection\n* vascular surgery is not indicated\n* There is no obstruction to apply MLD and compression to lower extremty\n\nExclusion Criteria:\n\n* with diabetic mellutus\n* with enfection\n* with ABI\\<0,7\n* Patients who have undergone venous vascular surgery\n* Patients undergoing active wound closure treatment'}, 'identificationModule': {'nctId': 'NCT04461132', 'briefTitle': 'The Effect of Manual Lymphatic Drainage', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Investigation of the Effect of Manual Lymphatic Drainag on Venous Ulcer Healing Rate', 'orgStudyIdInfo': {'id': '09.2017.209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Lymphatic Drainage Group', 'description': 'All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included manual lymphatic drainage on the leg, skin care, bandaging and exercise.', 'interventionNames': ['Other: Manual Lymphatic drainage (MLD)', 'Other: Skin Care', 'Other: Exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Shame Manual Lymphatic Drainage Group', 'description': 'All patients were treated 3 times a week for 4 weeks. The treatment program of these patients included shame manual lymphatic drainage on the leg, skin care, bandaging and exercise. Shame manual lymphatic drainage include light touches instead of real manual lymphatic drainage techniques', 'interventionNames': ['Other: Skin Care', 'Other: Exercise', 'Other: Shame Manual Lymphatic drainage']}], 'interventions': [{'name': 'Manual Lymphatic drainage (MLD)', 'type': 'OTHER', 'description': 'MLD vith vodder technique was applied to leg', 'armGroupLabels': ['Manual Lymphatic Drainage Group']}, {'name': 'Skin Care', 'type': 'OTHER', 'description': 'Wound was cleaned with salin and covered by dressing without including active products', 'armGroupLabels': ['Manual Lymphatic Drainage Group', 'Shame Manual Lymphatic Drainage Group']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'breathing and foot pump exercise was prescribed', 'armGroupLabels': ['Manual Lymphatic Drainage Group', 'Shame Manual Lymphatic Drainage Group']}, {'name': 'Shame Manual Lymphatic drainage', 'type': 'OTHER', 'description': 'manual lymphatic drainage was applied with light touch instead of real mld techniques', 'armGroupLabels': ['Shame Manual Lymphatic Drainage Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Saglık Bilimleri University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nilüfer Kablan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Health science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul Health Sciences University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}