Limb IschemiaNCT06357936
Nanofat Grafting as a Method of Treating Critical Limb Ischemia
A study testing nano-fat grafting in chronic limb ischaemia in people with Limb Ischemia, run by Center of New Medical Technologies at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Limb Ischemia
- What is being tested?
- nano-fat grafting in chronic limb ischaemia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 20 Apr 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Inability to undergo examinations at control points.
- Refusal to sign informed consent for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibirsk Oblast, 630090
Andrey V Ponomarenko, MD
About this study
Official title: Nanofat Grafting as a Method of Treating Critical Limb Ischemia - Pilot, Prospective Randomised Blinded Trial
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.
Read more
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.
- Conditions
- Limb Ischemia
- Being tested
- nano-fat grafting in chronic limb ischaemia, sham comparator
- Keywords
- Nano fat grafting, Critical limb ischemia, Autologous stem cells, Limb preservation
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano-fat grafting in chronic limb ischaemiaProcedure or surgery
The nano fat grafting procedure in the clinical trial involves the collection of adipose tissue under tumescent anesthesia, which is a technique to swell and firm the targeted area, through a separate puncture in the anterior abdominal wall. Following the collection, the adipose tissue undergoes a process of cannulation to prepare the nano fat. This prepared material is then injected into the tissues of the foot and leg using standard intramuscular injection needles. The injections are performed in various directions to ensure proper distribution of the nano fat. This method does not require additional drug therapy. It leverages the natural growth factors and stem cells present in adipose tissue, aiming to improve blood flow and tissue regeneration in limbs affected by critical ischemia. The unique aspect of this treatment is its focus on using autologous materials, minimizing the risk of rejection and side effects associated with foreign substances.
sham comparatorProcedure or surgery
For the clinical trial, a sham procedure would be designed to mimic the nano fat grafting without providing the actual therapeutic intervention. This involve the patient undergoing a similar process with tumescent anesthesia and making a puncture on the anterior abdominal wall. However, instead of harvesting adipose tissue and preparing nano fat, a placebo solution (such as saline) would be injected using the same intramuscular injection technique. The aim of this sham comparator is to assess the psychological and physiological effects of the nano fat grafting procedure itself, by eliminating the potential therapeutic benefits of the nano fat.
| Study group | Role | What they receive |
|---|---|---|
| nano fat grafting group | Experimental | Not described Receives: Procedure: nano-fat grafting in chronic limb ischaemia |
| standard therapy group | Sham comparator | Not described Receives: Procedure: sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of pain absence in experimental group
Measured: 12 months
Secondary outcomes (4)
Number of any intraoperative complications
Measured: 12 months
Number of any inhospital complications
Measured: 12 months
Number of saved limbs
Measured: 12 months
Percent change in visual analog pain score (VAS) change
The Visual Analogue Scale (VAS) is a straightforward, tool for measuring pain intensity or other subjective experiences that are difficult to quantify, such as fatigue or nausea. It consists of a straight line, usually 10 centimeters (100 millimeters) long, anchored by two descriptors defining the extremes of the experience being measured (e.g., "no pain" on one end and "worst imaginable pain" on the other for pain measurement).. The result is typically recorded in millimeters, with scores ranging from 0 to 100, where 0 represents one extreme (e.g., no pain) and 100 represents the other (e.g., worst imaginable pain).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center of New Medical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357936
- Sponsor's protocol ID
- CNMT002
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanofat Grafting as a Method of Treating Critical Limb Ischemia - Pilot, Prospective Randomised Blinded Trial
- ClinicalTrials.gov ID
- NCT06357936
- Acronym / sponsor ID
- CNMT002
- Conditions
- Limb Ischemia
- Keywords
- Nano fat grafting, Critical limb ischemia, Autologous stem cells, Limb preservation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center of New Medical TechnologiesUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nano fat grafting group | Experimental | Procedure: nano-fat grafting in chronic limb ischaemia |
| standard therapy group | Sham comparator | Procedure: sham comparator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nano-fat grafting in chronic limb ischaemiaThe nano fat grafting procedure in the clinical trial involves the collection of adipose tissue under tumescent anesthesia, which is a technique to swell and firm the targeted area, through a separate puncture in the anterior abdominal wall. Following the collection, the adipose tissue undergoes a process of cannulation to prepare the nano fat. This prepared material is then injected into the tissues of the foot and leg using standard intramuscular injection needles. The injections are performed in various directions to ensure proper distribution of the nano fat. This method does not require additional drug therapy. It leverages the natural growth factors and stem cells present in adipose tissue, aiming to improve blood flow and tissue regeneration in limbs affected by critical ischemia. The unique aspect of this treatment is its focus on using autologous materials, minimizing the risk of rejection and side effects associated with foreign substances. | Procedure or surgery | nano fat grafting group |
| sham comparatorFor the clinical trial, a sham procedure would be designed to mimic the nano fat grafting without providing the actual therapeutic intervention. This involve the patient undergoing a similar process with tumescent anesthesia and making a puncture on the anterior abdominal wall. However, instead of harvesting adipose tissue and preparing nano fat, a placebo solution (such as saline) would be injected using the same intramuscular injection technique. The aim of this sham comparator is to assess the psychological and physiological effects of the nano fat grafting procedure itself, by eliminating the potential therapeutic benefits of the nano fat. | Procedure or surgery | standard therapy group |
Primary outcome
Percent of pain absence in experimental group
Time frame: 12 months
4 secondary outcomes
Number of any intraoperative complications
Time frame: 12 months
Number of any inhospital complications
Time frame: 12 months
Number of saved limbs
Time frame: 12 months
Percent change in visual analog pain score (VAS) change
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nano-fat grafting in chronic limb ischaemia in people with Limb Ischemia, run by Center of New Medical Technologies at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey V Ponomarenko, MD (+79628316017, ponomarenko_av@cnmt.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of pain absence in experimental group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.