Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Critical Limb Ischemia, Peripheral Arterial Disease - PAD, Ischemic Ulcer
About this trial
This is an interventional treatment trial for Critical Limb Ischemia
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Established diagnosis of CLI according to TransAtlantic InterSociety Consensus (TASC II) guidelines
- Ankle oxygen partial pressure < 40 mmHg with no ischaemic lesions or < 60 mmHg with ischaemic lesions
- Tibial injections site free from ulcers
- Absence of comorbidities responsible for life expectancy < 6 months
- Non suitability for surgery (comorbidities or angiographic results)
- Informed consent taken
Exclusion Criteria:
- Age < 18 years
- Inability of understanding and signing informed consent
- Tibial injections sites involved by ulcers
- Life expectancy < 6 months
- Unwillingness to attend follow up
- Any of the following: women who are or may be pregnant or women hoping to become pregnant; women who are breastfeeding; men whose partners hope to become pregnant during the treatment period
Sites / Locations
- Fondazione IRCCS Ca' Granda Ospedale Maggiore di MilanoRecruiting
Arms of the Study
Arm 1
Experimental
Patients with critic limb ischemia
Patient enrolled from emergency room or outpatient population undergo pre-operatory tests including blood test, thoracic radiography, electrocardiogram, cardiologic visit, TcPO2 measurement and Doppler ultrasonography. During surgery the terminal branches of the patient's leg arteries are mapped and under local anesthesia multiple injections (1 mL each) of the adipose tissue formulation are inoculated 1 cm above the end of the terminal branch of the peroneal, anterior, and posterior tibial arteries. Furthermore, a total amount of 0.5-1 ml of the autologous adipose tissue-derived cell (ATDC) fraction is injected 1 cm near to ischaemic lesions. After the surgical procedure, the patient will be followed for 6 months, during which he will undergo outpatient visits at 7 and 21 days; then at 1, 3 and 6 months. At each visit, the patient will be assessed for the amount of pain, the transcutaneous oximetry value, measurement of the ABI index, arterial ultrasound Doppler lower limbs.