NCT03276312

Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot

Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.

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 objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps that lead to a revision of the amputation stump or amputation at a higher level); 5) evaluation of the time of hospitalization and quality of life (QoL).

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DEVICE	Lipogems	Lipogems® is an innovative system that, starting from minimum quantities of autologous lipoaspirate, provides, with a minimal manipulation, a micro-fragmented and non-expanded adipose tissue product

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-09-08
• Last updated: 2018-06-08

Locations

1 site across 1 country: Italy