Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-20 @ 11:30 AM
Study NCT ID:
NCT02512159
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Ulcers Treatment With an Handicraft Topical Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'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'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-07-29', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of granulation tissue in skin ulcers.', 'timeFrame': '10 days', 'description': 'Presence of granulation tissue in 50% of the wound'}], 'secondaryOutcomes': [{'measure': 'Leukocyte less than 11,000 mm3.', 'timeFrame': '10 days', 'description': 'Leukocyte less than 11,000 mm3.'}, {'measure': 'Temperature', 'timeFrame': '10 days', 'description': 'less than 38 ° C temperature.'}, {'measure': 'Breathing Rate', 'timeFrame': '10 days', 'description': 'less than 20 rpm breathing rate.'}, {'measure': 'Heart Rate', 'timeFrame': '10 days', 'description': 'lower heart rate 90 bpm.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic foot ulcer', 'Foot care', 'Wound management'], 'conditions': ['Foot Ulcer', 'Varicose Ulcer']}, 'referencesModule': {'references': [{'pmid': '27822727', 'type': 'DERIVED', 'citation': 'Gonzalez IG, Angel MA, Baez MV, Ruiz Flores B, de Los Angeles Martinez Ferretiz M, Woolf SV, Lopez I, Sandoval-Jurado L, Pat-Espadas FG, Cruz AA, Delgado AT. Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial. World J Surg. 2017 Feb;41(2):386-393. doi: 10.1007/s00268-016-3782-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.', 'detailedDescription': 'The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.\n2. Patients of both sexes.\n3. Patients over 18 years.\n4. Patients that have basic laboratory at admission (complete blood count with differential).\n5. Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.\n\nExclusion Criteria:\n\n1. Hemodynamically unstable patients.\n2. Patients with septic shock from any source.\n3. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.\n4. Patients with secondary cutaneous ulcer enteral fistula.\n5. Patients with cutaneous ulcer or cancer tumors.\n6. Patients with cutaneous ulcer with active bleeding.\n7. Patients with cutaneous ulcer necrosis.\n8. Patients with cutaneous ulcer leishmania, insect bite.\n9. Patients with cutaneous ulcer burns.\n10. Patients who do not accept their participation in the study through informed consent.'}, 'identificationModule': {'nctId': 'NCT02512159', 'briefTitle': 'Skin Ulcers Treatment With an Handicraft Topical Device', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Effectiveness of Topical Negative Handicraft Device for Versus Traditional Conservative Treatment in Skin Ulcers Management in Lower Limb', 'orgStudyIdInfo': {'id': '2014-2301-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'drenovac handcrafted', 'description': 'Patients treatment with the handicraft topical device negative pressure therapy Economic craft', 'interventionNames': ['Procedure: drenovac handcrafted']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healing', 'description': 'Patients who were managed with traditional "conservative treatment".', 'interventionNames': ['Procedure: Healing']}], 'interventions': [{'name': 'drenovac handcrafted', 'type': 'PROCEDURE', 'description': 'under local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours.', 'armGroupLabels': ['drenovac handcrafted']}, {'name': 'Healing', 'type': 'PROCEDURE', 'description': 'Were handled as follows:\n\n1. Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze.\n2. healing of skin ulcers were performed every 24 hours.\n3. the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables.', 'armGroupLabels': ['Healing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fany Guadalupe Pat Espadas, MCs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMSS'}, {'name': 'Israel Augusto González González, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'IMSS'}, {'name': 'Luis Sandoval Jurado, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IMSS'}, {'name': 'Ma. Valeria Jiménez Baéz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IMSS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}