Status:
COMPLETED
Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot
Lead Sponsor:
University of Modena and Reggio Emilia
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for...
Detailed Description
Primary objective of this study is the evaluation of the time of the healing of the lesions resulting from minor amputations (digital or forefoot) treated with Lipogems® technique. Secondary objectiv...
Eligibility Criteria
Inclusion
- Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the age of 18 years.
- Presence of irreversible gangrene digital or localized at forefoot (with X-ray of the foot negative or positive for osteolytic lesions at phalanges and/or metatarsus).
- Patients with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to 0.7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to 0.6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30mmHg).
Exclusion
- Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
- Patient under steroid therapy
- Active vascular issues
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03276312
Start Date
April 1 2015
End Date
March 1 2018
Last Update
June 8 2018
Active Locations (1)
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1
University of Modena and Reggio Emilia
Modena, Italy, 41100