Status:
UNKNOWN
Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Critical Limb Ischemia
Peripheral Arterial Disease - PAD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial ...
Detailed Description
The ADIPOCLI trial is an interventional monocentric trial in which the investigators will evaluate the safety, feasibility and potential efficacy of local administration of autologous adipose derived ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04746599
Start Date
January 1 2021
End Date
December 31 2022
Last Update
February 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano
Milan, Italy, 20121