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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lipogems
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Lipogems, Adipose-derived Mesenchymal Stem Cells, Lipofilling, Diabetic foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Modena and Reggio Emilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Lipogems - local injection of autologous micro-fragmented adipose tissue

Routine clinical practice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety: All types of adverse events will be collected
All types of adverse events will be collected
Incidence of relapse
Relapse is intended as revision of the amputation stump or amputation at a higher level
Pain assessed using the Visual Analogue Scale (VAS) for pain
Pain will be assessed using the VAS pain scale
Total time of hospitalization
Hospitalization of the patient will be assessed counting the number of days in hospital
Total time of immobility
Immobility of the patient will be assessed counting the number of bed rest days
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

Full Information

First Posted
July 24, 2017
Last Updated
June 6, 2018
Sponsor
University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT03276312
Brief Title
Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot
Official Title
Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Lipogems, Adipose-derived Mesenchymal Stem Cells, Lipofilling, Diabetic foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lipogems - local injection of autologous micro-fragmented adipose tissue
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine clinical practice
Intervention Type
Device
Intervention Name(s)
Lipogems
Intervention Description
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
Primary Outcome Measure Information:
Title
Healing time
Description
Healing time after the minor amputation intended as the complete healing of the amputation stump
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety: All types of adverse events will be collected
Description
All types of adverse events will be collected
Time Frame
6 months
Title
Incidence of relapse
Description
Relapse is intended as revision of the amputation stump or amputation at a higher level
Time Frame
6 months
Title
Pain assessed using the Visual Analogue Scale (VAS) for pain
Description
Pain will be assessed using the VAS pain scale
Time Frame
6 months
Title
Total time of hospitalization
Description
Hospitalization of the patient will be assessed counting the number of days in hospital
Time Frame
6 months
Title
Total time of immobility
Description
Immobility of the patient will be assessed counting the number of bed rest days
Time Frame
6 months
Title
Quality of Life using the Short Form 36 (SF-36) questionnaire
Description
Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Silingardi, Prof
Organizational Affiliation
Baggiovara Hospital, Vascular Surgery department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Modena and Reggio Emilia
City
Modena
ZIP/Postal Code
41100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34515448
Citation
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.
Results Reference
derived
PubMed Identifier
31358046
Citation
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.
Results Reference
derived

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

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