Tulavi Allay™ Nerve Cap for Pain After Digital Amputation
This study is looking at a new device called the Tulavi Allay™ Nerve Cap to help reduce pain after a finger or toe amputation. The cap is designed to protect cut nerves and prevent neuromas (painful nerve growths) from forming. Researchers want to see if using this cap helps reduce pain and improve daily activities for people who have had a digital amputation. You might be able to join if you are at least 22 years old, speak English, and are having a traumatic amputation of a finger or toe. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
- What's involved
- You would be evaluated for pain levels using questionnaires at 12 months after your amputation.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the procedure to assess pain and daily function.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Visual Analog / Numerical Rating Scale (VAS/NRS) Scores)12 months
• 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.
- • Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI)12 months
• 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).
- Cold Intolerance Symptom Severity score (CISS)12 months
• 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.