Status:
RECRUITING
Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)
Lead Sponsor:
Gregand Innovations
Collaborating Sponsors:
Clin-Experts
Conditions:
Neuropathic Pain
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Neuropathic pain is common in limb amputees and causes reductions in activity and participation as well as impaired quality of life. Some of these pains lead to the diagnosis of a responsible lesion a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04748484
Start Date
April 21 2021
End Date
March 1 2025
Last Update
May 29 2024
Active Locations (4)
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1
Hôpital d'Instruction des Armées Percy -
Clamart, France, 92140
2
Irr Nancy
Nancy, France, 54000
3
CRF La Tourmaline
Saint-Herblain, France, 44818
4
Institut Universitaire de Réadaptation Clemenceau
Strasbourg, France, 67000