Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:41 AM
Study NCT ID:
NCT06499506
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2024-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-16', 'releaseDate': '2025-06-29'}], 'estimatedResultsFirstSubmitDate': '2025-06-29'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparison between Skew flap and long posterior flap for below knee amputation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing', 'timeFrame': '6 month', 'description': 'Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility'}, {'measure': 'Re ampuation', 'timeFrame': '1 month', 'description': 'Rate of reamputation at (a) same level; (b) higher level.'}, {'measure': 'Mobilization', 'timeFrame': '6 month', 'description': 'Number of participants mobilizing with a prosthetic limb.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 month', 'description': 'Thirty-day mortality rate.'}, {'measure': 'Hospital stay', 'timeFrame': '1 month', 'description': 'Length of hospital stay.'}, {'measure': 'complaints', 'timeFrame': '2 month', 'description': 'Symptoms relating to the stump, such as pain and swelling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot', 'Ischemic Leg']}, 'descriptionModule': {'briefSummary': 'Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those with extensive venous ulceration; or following major trauma. and in the case of extremity sepsis.\n\nThere is two main methods for constructing the myocutaneous flaps in below knee amputation; the long posterior flap (LPF) and skew flap (SF).', 'detailedDescription': 'Anesthesia BKA could be performed under general anesthesia (GA), epidural anesthesia or under spinal anesthesia .\n\nPatient position The patient lies in the supine position. Technique The limb is prepared by an application of povidone iodine solution in the ward 2 h before surgery. The foot and any septic lesion is isolated. The whole limb is wrapped in a dry sterile sheet. Penicillin and metronidazole prophylaxis is used routinely.\n\nThe operation is performed under general anesthesia with a regional anesthetic technique.\n\nThe skin flaps are marked on the skin before any incision. And the skin flaps are semicircular. based on a line around the limb at right angles to its long axis, drawn at the plane of bone section 10-12cm from the joint line at the tibial plateau.\n\nThe skin flaps are cut which includes the fat and deep fascia. but these are not stripped from the underlying muscle more than is required to gain access to the anterior tibial compartment. The saphenous veins are ligated. The periosteum over the tibia is incised where it is exposed and elevated with the skin flap to 2 cm above the line of bone section.\n\nThe anterior tibial nerve and the peroneal nerve are divided and allowed to retract while the vessels are ligated. The fibula is divided 2cm above the line of tibial bone section.\n\nThe tibia is divided with a GIGLI saw. Traction on the bone hook exposes the tibialis posterior muscle and this is divided at the line of distal bone section which exposes the posterior tibial artery and its venae comitantes. the posterior tibial nerve and the peroneal artery and its venae comitantes. ligatures applied to each of the vascular bundles. The gastrocnemius and soleus muscle mass can then be separated from the tibia and fibula of the specimen while hemostasis is maintained. The muscle mass is cut transversely, thus freeing the specimen; this must allow a length of muscle below the bone end at least equal to the diameter of the leg.\n\nThe protruding muscle mass is then thinned from the line of bone section to its extremity .\n\nCareful homeostasis is essential and the muscle must not be compressed due to too much bulk or tight constricting sutures.\n\nA suction tube drain is drawn through the lateral aspect of the stump above the suture line and placed to collect any fluid in the vicinity of the bone ends.\n\nThe drain can be removed in 48-72 h; the sutures are removed at 15- 21 days. Follow up Patients will be followed up prospectively intraoperative, during postoperative hospital admission and late in outpatient clinic.\n\nMajor adverse clinical events (MACE) are carefully monitored. Follow up include immediate postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic atherosclerotic occlusive disease of the lower extremity and threatening limb ischemia (intractable rest pain, ulcer or gangrene) for whom all other treatment options failed or inapplicable .\n* patients with aggressive diabetic foot infections or gangrene, or both.\n* Patients with extensive venous ulceration.\n* Patients following major trauma with unsalvageable limb.\n* Patients with nonfunctioning damaged limb as in Charcot joint disease.\n* Patients with extensive limb sepsis.\n\nExclusion Criteria:\n\n* Patients with local site infection not candidate for instant closure.\n* Patients with bad general condition.'}, 'identificationModule': {'nctId': 'NCT06499506', 'briefTitle': 'Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes', 'orgStudyIdInfo': {'id': 'Soh-Med-24-06-15MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Skew Flap', 'description': 'skew Flap technique for below knee amputation', 'interventionNames': ['Procedure: Below knee amputation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long Posterior Flap', 'description': 'Long Posterior Flap for Below knee amputation', 'interventionNames': ['Procedure: Below knee amputation']}], 'interventions': [{'name': 'Below knee amputation', 'type': 'PROCEDURE', 'description': 'trans tibial amputation one hand breadth below tibial tuberosity', 'armGroupLabels': ['Long Posterior Flap', 'Skew Flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ibrahim', 'investigatorFullName': 'Mohamed Ibrahim Abdelmageed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-29', 'type': 'RELEASE'}, {'date': '2025-07-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Ibrahim Abdelmageed, Ibrahim, Sohag University'}}}}