Nanofat Grafting as a Method of Treating Critical Limb Ischemia - Pilot, Prospective Randomised Blinded Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Center of New Medical Technologies
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percent of pain absence in experimental group
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with occlusive lesions of the femoral-popliteal-tibial segment.
- •Chronic ischemia of the lower limbs of III-IV degree according to Fontaine and categories 5-6 according to Rutherford.
- •Signed informed consent for participation in the clinical trial.
Exclusion Criteria
- •Absence of indications for surgical intervention on the femoral-popliteal-tibial segment.
- •Patients refusing to participate in the clinical trial.
- •Chronic heart failure of III-IV NYHA functional class.
- •Chronic decompensated "pulmonary" heart.
- •Severe liver or kidney failure (bilirubin \>35 mmol/L, glomerular filtration rate \<60 ml/min).
- •Polivalent drug allergy.
- •Malignant oncological diseases in the terminal stage with a life expectancy of less than 6 months.
- •Acute cerebrovascular accident.
- •Decompensated diseases of the endocrine organs (for diabetes, glycemia level more than 10 mmol/L).
- •Pregnancy and lactation period.
Outcomes
Primary Outcomes
Percent of pain absence in experimental group
Time Frame: 12 months
Secondary Outcomes
- Number of any intraoperative complications(12 months)
- Number of any inhospital complications(12 months)
- Percent change in visual analog pain score (VAS) change(12 months)
- Number of saved limbs(12 months)