Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04093635
Status:
UNKNOWN
Last Update Posted:
2019-09-18
First Post:
2019-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Management of diabetic foot ulcers.', 'timeFrame': 'one year', 'description': 'Assessment role of negative pressure wound therapy in treating diabetic foot ulcers.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer']}, 'referencesModule': {'references': [{'pmid': '29969521', 'type': 'BACKGROUND', 'citation': 'Iheozor-Ejiofor Z, Newton K, Dumville JC, Costa ML, Norman G, Bruce J. Negative pressure wound therapy for open traumatic wounds. Cochrane Database Syst Rev. 2018 Jul 3;7(7):CD012522. doi: 10.1002/14651858.CD012522.pub2.'}, {'pmid': '28458556', 'type': 'BACKGROUND', 'citation': 'Liu S, He CZ, Cai YT, Xing QP, Guo YZ, Chen ZL, Su JL, Yang LP. Evaluation of negative-pressure wound therapy for patients with diabetic foot ulcers: systematic review and meta-analysis. Ther Clin Risk Manag. 2017 Apr 18;13:533-544. doi: 10.2147/TCRM.S131193. eCollection 2017.'}, {'pmid': '31007506', 'type': 'BACKGROUND', 'citation': 'James SMD, Sureshkumar S, Elamurugan TP, Debasis N, Vijayakumar C, Palanivel C. Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial. Niger J Surg. 2019 Jan-Jun;25(1):14-20. doi: 10.4103/njs.NJS_14_18.'}, {'pmid': '30099674', 'type': 'BACKGROUND', 'citation': 'Borys S, Hohendorff J, Koblik T, Witek P, Ludwig-Slomczynska AH, Frankfurter C, Kiec-Wilk B, Malecki MT. Negative-pressure wound therapy for management of chronic neuropathic noninfected diabetic foot ulcerations - short-term efficacy and long-term outcomes. Endocrine. 2018 Dec;62(3):611-616. doi: 10.1007/s12020-018-1707-0. Epub 2018 Aug 11.'}, {'pmid': '30498354', 'type': 'BACKGROUND', 'citation': 'Hu X, Lian W, Zhang X, Yang X, Jiang J, Li M. Efficacy of negative pressure wound therapy using vacuum-assisted closure combined with photon therapy for management of diabetic foot ulcers. Ther Clin Risk Manag. 2018 Oct 25;14:2113-2118. doi: 10.2147/TCRM.S164161. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers\n\n• The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.', 'detailedDescription': "Diabetic Foot ulcers are a major cause of admission in diabetic patients, and comprise a disproportionately high number of hospital days because of multiple surgical procedures and prolonged length of stay in Hospital.\n\nThe improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate. The approach to diabetic foot ulcers has allowed the availability of several medical options to ensure the best local condition and wound healing.\n\nNegative-pressure wound therapy is a non-invasive therapy system that employs a controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a container.\n\nAn earlier study has shown that NPWT reduced the need for subsequent amputations in a 6-month follow-up period. This reflects the importance of this device in management of DFUs and prevents its complications.\n\nAs most of the diabetic wounds present with infection, the success of NPWT is still highly dependent upon the adequacy of surgical debridement and antimicrobial coverage.\n\nNPWT provides a moist wound environment ideal for re-epithelialization, growth factor action, angiogenesis, and granulation promotion.\n\nEdema reduction produced by NPWT decreases interstitial pressure and positively promoting wound vessel formation and improving wound circulation and lymphatic drainage, increasing the availability of nutrients, oxygen and antibiotic therapy in the wound area. Some studies showed that NPWT promotes an improvement of balance between proteases and their inhibitors and influences cytokine modulation and promotes a positive wound environment.\n\nAccurate classification of diabetic foot ulcers according to Wagner's classification of ulcers is essential for inter-clinician communication, assessment of healing tendency during management by NPWT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include patients diagnosed as DFU from November 2019 to November 2020 at Assiut University Hospital.\n\nThe patients will divide into two groups:\n\nGroup I: Those patients that will be treated by NPWT. Group II: Those patients will be treated with standard saline moist wound care and dressing.\n\nEach group consists of 20 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute and chronic diabetic wounds, pressure ulcers.\n* Wagener's Grade I superficial diabetic ulcer.\n* Wagener's Grade II after surgical debridement and an appropriate antibiotic therapy.\n* Ischemic wounds after revascularization.\n\nExclusion Criteria:\n\n* \\- Wagener's Grade III, osteomyelitis and Charcot's joint septic arthritis.\n* Wagener's Grade IV, localized gangrene e.g. toe ,heel.\n* Wagener's Grade V, extensive gangrene involving the whole foot.\n* Septicemia. .\n* Gas forming organism.\n* Wounds resulting from venous insufficiency.\n* Peripheral vascular disease (absent distal pulse).\n* Patients being treated with corticosteroids, immunosuppressive drugs or chemotherapy\n* Any other serious pre-existing cardiovascular, pulmonary and immunological disease."}, 'identificationModule': {'nctId': 'NCT04093635', 'briefTitle': 'Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'VAC in DFUs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Those patients that will be treated by NPWT.', 'interventionNames': ['Device: Negative Pressure Wound Therapy']}, {'label': 'Group II', 'description': 'Those patients will be treated with standard saline moist wound care and dressing.', 'interventionNames': ['Device: Negative Pressure Wound Therapy']}], 'interventions': [{'name': 'Negative Pressure Wound Therapy', 'type': 'DEVICE', 'description': "VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall-mounted suction device and the pressure will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs", 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelrahman Ibrahim', 'role': 'CONTACT', 'email': 'abdoibrahim93@yahoo.com', 'phone': '01009842539'}, {'name': 'Mustafa Saad', 'role': 'CONTACT', 'email': 'moskavasc@yahoo.com', 'phone': '01020990128'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgery Department, Assiut University', 'investigatorFullName': 'Abdelrahman Ibrahim Sayed', 'investigatorAffiliation': 'Assiut University'}}}}