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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: Lipogems


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions Patient under steroid therapy Active vascular issues

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Lipogems - local injection of autologous micro-fragmented adipose tissue | Device: Lipogems<br>* 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<br>|
| No Intervention: Control<br>Routine clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing time | Healing time after the minor amputation intended as the complete healing of the amputation stump | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: All types of adverse events will be collected | All types of adverse events will be collected | 6 months | 
| Incidence of relapse | Relapse is intended as revision of the amputation stump or amputation at a higher level | 6 months | 
| Pain assessed using the Visual Analogue Scale (VAS) for pain | Pain will be assessed using the VAS pain scale | 6 months | 
| Total time of hospitalization | Hospitalization of the patient will be assessed counting the number of days in hospital | 6 months | 
| Total time of immobility | Immobility of the patient will be assessed counting the number of bed rest days | 6 months | 
| Quality of Life using the Short Form 36 (SF-36) questionnaire | Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipogems, Adipose-derived Mesenchymal Stem Cells, Lipofilling, Diabetic foot