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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276312
• Other study ID #: ADF01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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

Locations

Country	Name	City	State
Italy	University of Modena and Reggio Emilia	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time	Healing time after the minor amputation intended as the complete healing of the amputation stump	6 months
Secondary	Safety: All types of adverse events will be collected	All types of adverse events will be collected	6 months
Secondary	Incidence of relapse	Relapse is intended as revision of the amputation stump or amputation at a higher level	6 months
Secondary	Pain assessed using the Visual Analogue Scale (VAS) for pain	Pain will be assessed using the VAS pain scale	6 months
Secondary	Total time of hospitalization	Hospitalization of the patient will be assessed counting the number of days in hospital	6 months
Secondary	Total time of immobility	Immobility of the patient will be assessed counting the number of bed rest days	6 months
Secondary	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