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

June 6, 2018 updated by: Giulia Trevisi Borsari, University of Modena and Reggio Emilia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41100
        • University of Modena and Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the age of 18 years.
  2. 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).
  3. 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:

  1. Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
  2. Patient under steroid therapy
  3. Active vascular issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Lipogems - local injection of autologous micro-fragmented adipose tissue
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
NO_INTERVENTION: Control
Routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time
Time Frame: 6 months
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
Time Frame: 6 months
All types of adverse events will be collected
6 months
Incidence of relapse
Time Frame: 6 months
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
Time Frame: 6 months
Pain will be assessed using the VAS pain scale
6 months
Total time of hospitalization
Time Frame: 6 months
Hospitalization of the patient will be assessed counting the number of days in hospital
6 months
Total time of immobility
Time Frame: 6 months
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
Time Frame: 6 months
Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Investigators

  • Principal Investigator: Roberto Silingardi, Prof, Baggiovara Hospital, Vascular Surgery department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (ACTUAL)

September 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADF01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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