Distal Amputation of the FingersLIPOFILLINGNCT04076397
Lipofilling Versus Conservative Treatment in Fingertips Injuries Sequelae
A study testing autologous transplant reinjection and desensitization in people with Distal Amputation of the Fingers, run by University Hospital, Brest at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Amputation of the Fingers
- What is being tested?
- autologous transplant reinjection and desensitization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jul 2020to 2 Jul 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient (18 years old) and ≤ 75 years old
- Patient with unidigital trauma downstream of distal interphalangeal joint
- Treated by directed healing OR covered by a flap
- Presenting troublesome pulpal dysesthesia evolving for more than 6 months AND less than 24 months
- The discomfort must be objectified by a DN4 score greater than or equal to 4/10 (neuropathic pain)
- Patient does not have any allergy to the substances used, in particular anesthetic: xylocaine, adrenaline
Who cannot join
- Patient with cutaneous sepsis, or amputation upstream of distal interphalangeal, or reimplantation, or dysesthesia that has been in progress for more than 24 months, or multi-digital traumatism
- Refusal of the patient to integrate the protocol Or incapacity to consent
- Pregnant or breastfeeding woman
- Tumor history of the amputated finger
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Brest
Brest, 29200
CH de Cornouaille - Quimper
Quimper, 29107
About this study
Official title: Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study
The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.
- Conditions
- Distal Amputation of the Fingers
- Being tested
- autologous transplant reinjection, desensitization
- Keywords
- annoying pulpal dysesthesia, lipofilling, amputation, sequelae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous transplant reinjectionProcedure or surgery
The patient is placed under loco-regional anesthesia. After sterilization of the upper limb and abdomen, the fat is removed at a fold by micro-incision by the Coleman method. The fat is decanted and micro-reinjected into the pulp of the patient's finger with 2 or 3 punctiform incisions. The quantity of fat injected is 2 to 3 mL. Incision of the abdomen and fingers is closed by points at monocryl 4/0. Finally, a fatty dressing is performed on the finger. Patients will benefit from nursing care every 2 days
desensitizationOther
Patients will have to stimulate the pulp of your finger on a daily basis
| Study group | Role | What they receive |
|---|---|---|
| lipofilling group | Other | Patient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations:
* Make EVA (evaluation of the pain),
* Complete DASH questionnaire
* Complete DN4 questionnaire
Patients in the lipofilling group will also have:
* the repair of the last dressing during the consultation at J15
* Ablation of any threads
* Control of the digital and abdominal scar
* Making a photo of their finger at V1 and M6 Receives: Procedure: autologous transplant reinjection |
| desensitization group | Other | Patient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations:
* Make EVA (evaluation of the pain),
* Complete DASH questionnaire
* Complete DN4 questionnaire Receives: Other: desensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the EVA between D0 and M6
visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort
Measured: Day 0, Month 6
Secondary outcomes (1)
Subjective self-assessment of the overall functional ability of both upper limbs
DASH questionnaire (Disability of Arm-Shoulder-Hand)
Measured: Day 0, Day 15, Month1, Month3, Month6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start2 Jul 2020
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Why it stopped: The inclusion objective has not been achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Amputation of the FingersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1: 1) with stratification on the center, the type of initial surgery (directed or flap scarring) and the duration of change of dysesthesia (≤ or\> 1 year at baseline).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076397
- Sponsor's protocol ID
- 29BRC19.0081
- Acronym
- LIPOFILLING
- Status last verified
- May 2026
- First submitted
- 29 Aug 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study
- ClinicalTrials.gov ID
- NCT04076397
- Acronym / sponsor ID
- LIPOFILLING / 29BRC19.0081
- Conditions
- Distal Amputation of the Fingers
- Keywords
- annoying pulpal dysesthesia, lipofilling, amputation, sequelae
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The inclusion objective has not been achieved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 3 Sep 2019 (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.
The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1: 1) with stratification on the center, the type of initial surgery (directed or flap scarring) and the duration of change of dysesthesia (≤ or> 1 year at baseline).
| Arm | Type | Receives |
|---|---|---|
| lipofilling group | Other | Procedure: autologous transplant reinjectionPatient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations: * Make EVA (evaluation of the pain), * Complete DASH questionnaire * Complete DN4 questionnaire Patients in the lipofilling group will also have: * the repair of the last dressing during the consultation at J15 * Ablation of any threads * Control of the digital and abdominal scar * Making a photo of their finger at V1 and M6 |
| desensitization group | Other | Other: desensitizationPatient will conduct a total of 4 visits: D15, M1, M3, M6 during which they will have: a clinical examination as well as the following evaluations: * Make EVA (evaluation of the pain), * Complete DASH questionnaire * Complete DN4 questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major patient (18 years old) and ≤ 75 years old
- Patient with unidigital trauma downstream of distal interphalangeal joint
- Treated by directed healing OR covered by a flap
- Presenting troublesome pulpal dysesthesia evolving for more than 6 months AND less than 24 months
- The discomfort must be objectified by a DN4 score greater than or equal to 4/10 (neuropathic pain)
Key exclusion criteria (4 listed)
- Patient with cutaneous sepsis, or amputation upstream of distal interphalangeal, or reimplantation, or dysesthesia that has been in progress for more than 24 months, or multi-digital traumatism
- Refusal of the patient to integrate the protocol Or incapacity to consent
- Pregnant or breastfeeding woman
- Tumor history of the amputated finger
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 |
|---|---|---|
| autologous transplant reinjectionThe patient is placed under loco-regional anesthesia. After sterilization of the upper limb and abdomen, the fat is removed at a fold by micro-incision by the Coleman method. The fat is decanted and micro-reinjected into the pulp of the patient's finger with 2 or 3 punctiform incisions. The quantity of fat injected is 2 to 3 mL. Incision of the abdomen and fingers is closed by points at monocryl 4/0. Finally, a fatty dressing is performed on the finger. Patients will benefit from nursing care every 2 days | Procedure or surgery | lipofilling group |
| desensitizationPatients will have to stimulate the pulp of your finger on a daily basis | Other | desensitization group |
Primary outcome
Decrease of the EVA between D0 and M6
Time frame: Day 0, Month 6
visual analogue scale from 0 to 10, knowing that 0 is the absence of discomfort and intolerable discomfort
1 secondary outcome
Subjective self-assessment of the overall functional ability of both upper limbs
Time frame: Day 0, Day 15, Month1, Month3, Month6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous transplant reinjection and desensitization in people with Distal Amputation of the Fingers, run by University Hospital, Brest at 2 sites in France.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Decrease of the EVA between D0 and M6 (time frame: Day 0, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.