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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lipogems - local injection of autologous micro-fragmented adipose tissue |
|
| Control | No Intervention | Routine clinical practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipogems | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time | Healing time after the minor amputation intended as the complete healing of the amputation stump | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: All types of adverse events will be collected | All types of adverse events will be collected | 6 months |
| Incidence of relapse | Relapse is intended as revision of the amputation stump or amputation at a higher level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Silingardi, Prof | Baggiovara Hospital, Vascular Surgery department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Modena and Reggio Emilia | Modena | 41100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515448 | Derived | 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. | |
| 31358046 |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Randomized controlled study
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| 6 months |
| Pain assessed using the Visual Analogue Scale (VAS) for pain | Pain will be assessed using the VAS pain scale | 6 months |
| Total time of hospitalization | Hospitalization of the patient will be assessed counting the number of days in hospital | 6 months |
| Total time of immobility | 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 | Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire | 6 months |
| Derived |
| 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |