Comparing lipofilling and conservative treatment for fingertip injuries
Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study
NA · University Hospital, Brest · NCT04076397
This study is testing if a fat injection treatment can help people with fingertip injuries feel less pain and improve their sensation compared to regular treatment methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 2 sites (Brest and 1 other locations) |
| Trial ID | NCT04076397 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of autologous graft reinjection, known as lipofilling, in treating troublesome pulpal dysesthesia following distal finger amputations. Patients aged 18 to 75 with specific criteria related to their fingertip injuries will be enrolled to assess the impact of this intervention compared to conservative treatment methods. The study aims to objectively measure the discomfort experienced by patients using a standardized pain assessment tool. The goal is to determine if lipofilling can significantly improve patient outcomes in terms of sensation and pain relief.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unidigital trauma and persistent dysesthesia lasting between 6 to 24 months.
Not a fit: Patients with multi-digital trauma, long-standing dysesthesia over 24 months, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant relief from dysesthesia and improve the quality of life for patients with fingertip injuries.
How similar studies have performed: While the specific approach of lipofilling for this condition may be novel, similar interventions have shown promise in other areas of reconstructive surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Brest and 1 other locations
- CHRU de Brest — Brest, France (RECRUITING)
- CH de Cornouaille - Quimper — Quimper, France (RECRUITING)
Study contacts
- Study coordinator: Anne PERRUISSEAU-CARRIER, Dr
- Email: anne.perruisseaucarrier@chu-brest.fr
- Phone: 02.08.34.25.11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Distal Amputation of the Fingers, annoying pulpal dysesthesia, lipofilling, amputation, sequelae