protocolSection identificationModule nctId: NCT06357936, orgStudyIdInfo id: CNMT002, briefTitle: Nanofat Grafting as a Method of Treating Critical Limb Ischemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Center of New Medical Technologies, class: OTHER, descriptionModule briefSummary: This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments., conditionsModule conditions: Limb Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: nano-fat grafting in chronic limb ischaemia, interventions name: sham comparator, outcomesModule primaryOutcomes measure: Percent of pain absence in experimental group, secondaryOutcomes measure: Number of any intraoperative complications, secondaryOutcomes measure: Number of any inhospital complications, secondaryOutcomes measure: Number of saved limbs, secondaryOutcomes measure: Percent change in visual analog pain score (VAS) change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Andrey V Ponomarenko, MD, role: CONTACT, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False