Prevention of PostAmputation Pain with Targeted Muscle Reinnervation
Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Dec 2, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying ways to reduce pain after a lower extremity amputation, specifically focusing on phantom limb pain and pain in the remaining part of the limb. Researchers want to see whether a surgical technique called Targeted Muscle Reinnervation (TMR) can help lessen this pain compared to the standard method of nerve handling. TMR involves connecting the cut nerve to a muscle nerve to help prevent painful nerve growths known as neuromas. The trial will include patients aged 18 to 75 who are scheduled for an amputation due to vascular disease.
Participants will be randomly assigned to either receive the standard nerve handling or TMR during their surgery. After the surgery, they will complete several online questionnaires over the next year to track their pain levels, quality of life, and overall well-being. This trial is currently recruiting participants, but individuals with certain conditions—like those with traumatic amputations, existing nerve issues, or cognitive impairments—will not be eligible. The hope is that TMR will lead to less pain, improved quality of life, and lower healthcare costs for those who have undergone amputation.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients scheduled for a lower extremity amputation (transfemoral to transtibial) as a primary or secondary sequela of vascular disease.
- Exclusion Criteria:
- • Less than 18 years of age
- • Over 75 years of age
- • Other reasons for amputation besides a primary or secondary sequela of vascular disease (i.e., traumatic or neoplasms)
- • Insensate limbs at the level of amputation
- • CRPS (Complex Regional Pain Syndrome)
- • Existing neuroma or prior neuroma surgery in the affected limb
- • Physiologically unstable patients at the time of amputation
- • Cognitive impairment, delirium
- • Undergoing radiotherapy on the affected limb
- • Unfit for general anesthesia
- • No nerve surgeon available to perform TMR
About Leiden University Medical Center
Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Utrecht, , Netherlands
Leiden, South Holland, Netherlands
Rotterdam, South Holland, Netherlands
Zwolle, Overijssel, Netherlands
Amsterdam, North Holland, Netherlands
Leiderdorp, South Holland, Netherlands
The Hague, South Holland, Netherlands
Patients applied
Trial Officials
Justus L Groen, MD PhD
Principal Investigator
Leiden University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported