Evaluation of a connected medical device for managing neuropathic pain in amputees
Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)- Comprising a Sleeve and a Sock - in Amputees Suffering From Rebellious Neuropathic Pain on the Residual Limb and / or Phantom Limb
This study is testing a new connected device to see if it can help amputees manage their nerve pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gregand Innovations Industry-sponsored |
| Locations | 4 sites (Clamart and 3 other locations) |
| Trial ID | NCT04748484 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation focuses on the effectiveness of the Caloprothese Connected Kit (CCK) in alleviating neuropathic and phantom limb pain in patients with trans-femoral or trans-tibial amputations. The study aims to assess the device's impact on pain levels, activity, and quality of life for individuals experiencing significant residual limb pain. Participants will be monitored for pain intensity and frequency, utilizing validated pain scales and assessments. The approach emphasizes early multimodal reassignment techniques to enhance rehabilitation outcomes for amputees.
Who should consider this trial
Good fit: Ideal candidates include adults with trans-femoral or trans-tibial amputations experiencing moderate to severe residual limb pain.
Not a fit: Patients with bilateral lower limb amputations or those with specific stump pathologies causing pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce neuropathic pain and improve the quality of life for amputees.
How similar studies have performed: While there is existing research on multimodal rehabilitation techniques for amputees, the specific use of the CCK device represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clamart and 3 other locations
- Hôpital d'Instruction des Armées Percy - — Clamart, France (Recruiting)
- Irr Nancy — Nancy, France (Recruiting)
- CRF La Tourmaline — Saint-Herblain, France (Not_yet_recruiting)
- Institut Universitaire de Réadaptation Clemenceau — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Renaud Urbinelli
- Email: contact@clin-experts.fr
- Phone: +33658687286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.