NCT03276312

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

July 24, 2017

Last Update Submit

June 6, 2018

Conditions

Diabetic Foot

Keywords

LipogemsAdipose-derived Mesenchymal Stem CellsLipofillingDiabetic foot

Outcome Measures

Primary Outcomes (1)

  • Healing time

    Healing time after the minor amputation intended as the complete healing of the amputation stump

    6 months

Secondary Outcomes (6)

  • Safety: All types of adverse events will be collected

    6 months

  • Incidence of relapse

    6 months

  • Pain assessed using the Visual Analogue Scale (VAS) for pain

    6 months

  • Total time of hospitalization

    6 months

  • Total time of immobility

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Lipogems - local injection of autologous micro-fragmented adipose tissue

Device: Lipogems

Control

NO INTERVENTION

Routine clinical practice

Interventions

LipogemsDEVICE

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Modena and Reggio Emilia

Modena, 41100, Italy

Location

Related Publications (2)

  • Gennai S, Leone N, Covic T, Migliari M, Lonardi R, Silingardi R. Health-related quality of life outcomes and hospitalization length of stay after micro-fragmented autologous adipose tissue injection in minor amputations for diabetic foot ulceration (MiFrAADiF Trial): results from a randomized controlled single-center clinical trial. Int Angiol. 2021 Dec;40(6):512-519. doi: 10.23736/S0392-9590.21.04570-3. Epub 2021 Sep 13.

    PMID: 34515448DERIVED

  • Lonardi R, Leone N, Gennai S, Trevisi Borsari G, Covic T, Silingardi R. Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF). Stem Cell Res Ther. 2019 Jul 29;10(1):223. doi: 10.1186/s13287-019-1328-4.

    PMID: 31358046DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Roberto Silingardi, Prof

    Baggiovara Hospital, Vascular Surgery department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 24, 2017

First Posted

September 8, 2017

Study Start

April 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

June 8, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)