Diabetic FootNCT03276312
Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot
A study testing Lipogems in people with Diabetic Foot, run by University of Modena and Reggio Emilia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Lipogems
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
- Patient under steroid therapy
- Active vascular issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Diabetic Foot
- Being tested
- Lipogems
- Keywords
- Lipogems, Adipose-derived Mesenchymal Stem Cells, Lipofilling, Diabetic foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lipogems - local injection of autologous micro-fragmented adipose tissue Receives: Device: Lipogems |
| Control | No intervention | Routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Healing time after the minor amputation intended as the complete healing of the amputation stump
Measured: 6 months
Secondary outcomes (6)
Safety: All types of adverse events will be collected
All types of adverse events will be collected
Measured: 6 months
Incidence of relapse
Relapse is intended as revision of the amputation stump or amputation at a higher level
Measured: 6 months
Pain assessed using the Visual Analogue Scale (VAS) for pain
Pain will be assessed using the VAS pain scale
Measured: 6 months
Total time of hospitalization
Hospitalization of the patient will be assessed counting the number of days in hospital
Measured: 6 months
Total time of immobility
Immobility of the patient will be assessed counting the number of bed rest days
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study startApr 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Trevisi Borsari, University of Modena and Reggio Emilia
- Investigators
- Roberto Silingardi, Prof, Principal investigator, Baggiovara Hospital, Vascular Surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276312
- Sponsor's protocol ID
- ADF01
- Status last verified
- Jun 2018
- First submitted
- 24 Jul 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34515448Lonardi 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.
PubMed 31358046
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03276312
- Acronym / sponsor ID
- ADF01
- Conditions
- Diabetic Foot
- Keywords
- Lipogems, Adipose-derived Mesenchymal Stem Cells, Lipofilling, Diabetic foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LipogemsLipogems - local injection of autologous micro-fragmented adipose tissue |
| Control | No intervention | –Routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
- Patient under steroid therapy
- Active vascular issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipogemsLipogems® 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 | Device | Intervention |
Primary outcome
Healing time
Time frame: 6 months
Healing time after the minor amputation intended as the complete healing of the amputation stump
6 secondary outcomes
Safety: All types of adverse events will be collected
Time frame: 6 months
Incidence of relapse
Time frame: 6 months
Pain assessed using the Visual Analogue Scale (VAS) for pain
Time frame: 6 months
Total time of hospitalization
Time frame: 6 months
Total time of immobility
Time frame: 6 months
Quality of Life using the Short Form 36 (SF-36) questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Derived from this study: PubMed 34515448Gennai 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.
- Derived from this study: PubMed 31358046Lonardi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Silingardi, Prof principal investigator
Baggiovara Hospital, Vascular Surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipogems in people with Diabetic Foot, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.