Clinical trial · Interventional
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap: A Prospective Trial for Safety and Efficacy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroma | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tulavi allay Nerve Cap | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tulavi allay Nerve Cap
- description
- Arm 1 will include patients who satisfy the inclusion criteria and consent to the study enrollment and procedure. Surgeons will perform the procedure per their standard practice, but will use the allay™ Nerve Cap per the manufacturer's instructions to prevent potential symptomatic neuroma. All adult patients, satisfying the inclusion and exclusion criteria, are eligible for enrollment in this study regardless of sex, race, or ethnicity. Vulnerable populations will not be recruited.
- interventionNames
- Device: Tulavi allay Nerve Cap
Primary outcomes (3)
- measure
- Visual Analog / Numerical Rating Scale (VAS/NRS) Scores)
- timeFrame
- 12 months
- description
- • Numerical Rating Scale (NRS): is a standard pain scale measured on a 11 point (0-10) where 0=no pain and 10=worst possible pain. There are no values defined as a clinically important difference for painful conditions in amputated digits, but previous studies on chronic painful conditions define a reduction of 2 points as a clinically important difference.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing traumatic amputation of a single or multiple digits at MGB * English-speaking Exclusion Criteria: * Patients undergoing revision amputation or non-traumatic amputation * Patients under 22 years old * Patients who are pregnant and/or breastfeeding * Unable or unwilling to participate in a trial study * Patients with a known allergy to poly (ethylene glycol) (PEG) or the color additives FD\&C Yellow No. 5 Dye (tartrazine) or FD\&C Blue No. l Dye (brilliant blue FCF).
References
Publications (14)
- BACKGROUNDBelcher HJ, Pandya AN. Centro-central union for the prevention of neuroma formation after finger amputation. J Hand Surg Br. 2000 Apr;25(2):154-9. doi: 10.1054/jhsb.2000.0372. PMID 11062573
- BACKGROUNDReid DBC, Shah KN, Eltorai AEM, Got CC, Daniels AH. Epidemiology of Finger Amputations in the United States From 1997 to 2016. J Hand Surg Glob Online. 2019 Apr 1;1(2):45-51.
- BACKGROUNDTerwee CB, Peipert JD, Chapman R, Lai JS, Terluin B, Cella D, Griffiths P, Mokkink LB. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res. 2021 Oct;30(10):2729-2754. doi: 10.1007/s11136-021-02925-y. Epub 2021 Jul 10. PMID 34247326
- BACKGROUNDFarrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9. PMID 11690728
- BACKGROUNDKarcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6. PMID 29321111
- BACKGROUNDFreniere BB, Wenzinger E, Lans J, Eberlin KR. Relocation Nerve Grafting: A Technique for Management of Symptomatic Digital Neuromas. J Hand Microsurg. 2019 Oct;11(Suppl 1):S50-S52. doi: 10.1055/s-0038-1677320. Epub 2019 Jan 4. PMID 31616128
- BACKGROUNDTaras JS, Tadley M, McCabe L. Dorsal Coaptation for the Treatment of Digital Neuroma. J Hand Surg Am. 2021 Jun;46(6):514.e1-514.e5. doi: 10.1016/j.jhsa.2020.10.027. Epub 2020 Dec 27. PMID 33375993
- BACKGROUNDArnold DMJ, Wilkens SC, Coert JH, Chen NC, Ducic I, Eberlin KR. Diagnostic Criteria for Symptomatic Neuroma. Ann Plast Surg. 2019 Apr;82(4):420-427. doi: 10.1097/SAP.0000000000001796.