Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

NCT06915662 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 2025P000828
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neuroma; Neuropathic Pain

Keywords

Tulavi; Tulavi allay Nerve Cap; Neuroma; Neuropathic Pain; Digital Nerve Neuroma

Outcome Measures

Primary Outcomes (3)

• Visual Analog / Numerical Rating Scale (VAS/NRS) Scores)

  • 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.

  12 months

• • Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI)

  • Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI): this scale incorporates other aspects of pain that influence patient´s emotional and social life. We will use the most recent version PROMIS Pain Interference computer-adaptive testing (PROMIS IP CAT) that measures pain interference over the past 7 days. PROMIS scores have a mean of 50 and a SD of 10 in the reference population (U.S general population with a painful condition).

  12 months

• Cold Intolerance Symptom Severity score (CISS)

  • Cold Intolerance Symptom Severity score (CISS) is a 6 questions scale with a possible total score from 4-100. Each question has a score of 0=no symptoms to 10=the most severe symptoms you can possibly imagine (the first question does not count for the final score). Previous studies suggested CISS\>50 as a clinical cut-off for pathological cold intolerance.

  12 months

Study Arms (1)

Tulavi allay Nerve Cap

EXPERIMENTAL

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.

Device: Tulavi allay Nerve Cap

Interventions

Tulavi allay Nerve Cap DEVICE

The Tulavi allay Nerve Capfirst and only fully absorbable in situ forming technology designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation. https://tulavi.com/allay-nerve-cap/

Tulavi allay Nerve Cap

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing traumatic amputation of a single or multiple digits at MGB
• English-speaking

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Tulavi Therapeutics,Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (14)

• Belcher 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 BACKGROUND

• Reid 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.

  BACKGROUND

• Terwee 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 BACKGROUND

• Farrar 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 BACKGROUND

• Karcioglu 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 BACKGROUND

• Freniere 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 BACKGROUND

• Taras 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 BACKGROUND

• Arnold 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.

  PMID: 30855369 BACKGROUND

• Lans J, Baker DJ, Castelein RM, Sood RF, Chen NC, Eberlin KR. Patient-Reported Outcomes following Surgical Treatment of Symptomatic Digital Neuromas. Plast Reconstr Surg. 2020 Mar;145(3):563e-573e. doi: 10.1097/PRS.0000000000006552.

  PMID: 32097316 BACKGROUND

• Vlot MA, Wilkens SC, Chen NC, Eberlin KR. Symptomatic Neuroma Following Initial Amputation for Traumatic Digital Amputation. J Hand Surg Am. 2018 Jan;43(1):86.e1-86.e8. doi: 10.1016/j.jhsa.2017.08.021. Epub 2017 Sep 23.

  PMID: 28951100 BACKGROUND

• Phillips CJ. The Cost and Burden of Chronic Pain. Rev Pain. 2009 Jun;3(1):2-5. doi: 10.1177/204946370900300102.

  PMID: 26526940 BACKGROUND

• van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. 2014 Apr;155(4):654-662. doi: 10.1016/j.pain.2013.11.013. Epub 2013 Nov 26.

  PMID: 24291734 BACKGROUND

• Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.

  PMID: 30212442 BACKGROUND

• Stjernbrandt A, Liljelind I, Nilsson T, Wahlstrom J. Defining abnormal cold sensitivity using the Cold Intolerance Symptom Severity questionnaire: a population study. J Hand Surg Eur Vol. 2021 Sep;46(7):731-737. doi: 10.1177/1753193421996221. Epub 2021 Mar 12.

  PMID: 33709819 BACKGROUND

Related Links

• allay Nerve Cap webpage
• Tulavi Therapeutics Inc. website

MeSH Terms

Conditions

Neuroma; Neuralgia

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abhiram Bhashyam, MD, PhD

CONTACT

(617) 726 - 4700; abhashyam@mgb.org

Sujit Chepuri, BA

CONTACT

(617) 726 - 1569; schepuri@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Orthopaedic Surgery, Harvard Medical School

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available from the first enrolled patient (start date) until the final follow up of the last patient, 12 months after their procedure.
• Access Criteria: The full-time research coordinator and principal investigator are responsible for adherence to all IRB policies and guidelines and for the accuracy and completeness of all forms, entries, and informed consent. Study data will be maintained in a locked filing cabinet and/or on password-protected computers. Questionnaires and self-reported responses will not become part of the subject's medical record. Hardcopies of study related data and forms will be stored in a lockable file cabinet. Only the investigators and study staff will have access to this information. Any magnetic or electronic information will be saved in password-protected computers to which only research coordinator and persons involved with the research project will have access. RED Cap, secure and HIPAA-compliant, will be used to collect questionnaire answers. All patient-identifiable information will be collected in a separate data log. The Principal Investigator oversees and monitors this process.

Locations

US (1)