Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)

Launched by GREGAND INNOVATIONS · Feb 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Connected Caloprosthesis Kit (CCK), which aims to help patients with neuropathic pain or phantom limb pain after an amputation. Neuropathic pain is a type of pain that can be hard to treat and often affects the quality of life for amputees. The CCK device works by keeping the temperature of the residual limb (the part of the limb that remains after amputation) within a comfortable range, helping to reduce pain and improve overall comfort.

To be eligible for the trial, participants must be adults aged 65 or older who experience significant pain (rated 5 or higher on a scale of 10) at least once a week and have had a leg amputation for over a year. Patients with certain conditions or those who cannot use a smartphone are excluded from the study. Participants will wear the CCK device and be monitored over time to see how well it works in managing their pain. This trial is important because it not only tests a new treatment option but also helps researchers understand more about the nature of pain in amputees.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient seen in consultation motivated by residual limb pain
• • Adult with background pain (Lickert scale ≥ 5/10) or with pain attacks (Lickert scale ≥ 5/10) whose frequency is more than once per week
• • Patient with a DN4 score \> 4/10 (Score validated in neuropathic pain)
• • Patient with trans-femoral or trans-tibial amputation
• • Patient whose amputation was over 1 year ago regardless of the aetiology of his amputation.
• Exclusion Criteria:
• Patient :
• • under 18 year old
• • With a silicone allergy
• • Usually fitted by means of suspension by a seal in sleeve, by suspension by vacuum pump requiring a polyurethane sleeve
• • Presenting any pathology of the stump explaining the pain on clinical arguments, complemented if necessary by additional investigations: neuroma, bone or vascular pathology or conflicts with the socket...
• • With bilateral lower limb amputation
• • Not being able to use a Smartphone
• • Not wishing to participate in the study
• • Adult subject to legal protection or unable to express consent
• • Pregnant or breastfeeding females.