Clinical trial NCT03276312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Lipogems
Adipose-derived Mesenchymal Stem Cells
Lipofilling
Diabetic foot
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Healing time
timeFrame: 6 months
Secondary outcomes:
measure: Safety: All types of adverse events will be collected
timeFrame: 6 months
measure: Incidence of relapse
timeFrame: 6 months
measure: Pain assessed using the Visual Analogue Scale (VAS) for pain
timeFrame: 6 months
measure: Total time of hospitalization
timeFrame: 6 months
measure: Total time of immobility
timeFrame: 6 months
measure: Quality of Life using the Short Form 36 (SF-36) questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
Study officials:
affiliation: Baggiovara Hospital, Vascular Surgery department
name: Roberto Silingardi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.