Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK) (KCC)
Primary Purpose
Neuropathic Pain, Phantom Limb Pain
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KCC Active or inactive
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring phantom limb pain, SCED, medical device
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.
Sites / Locations
- Hôpital d'Instruction des Armées Percy -Recruiting
- Irr NancyRecruiting
- CRF La Tourmaline
- Institut Universitaire de Réadaptation Clemenceau
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
KCC active or inactive
Arm Description
The medical device KCC will be active, or inactive. Randomization will define when and how long time the medical device will be active, and when and how long time the medical device will be inactive. The patient won't know if the medical device is active or not. The battery charge indicator will work the same whether the device is operating or not.
Outcomes
Primary Outcome Measures
Intensity of the overall pain (background pain and paroxysmal pain) on 0-10 numerical scale
The primary judgment criteria will be the evaluation of the intensity of the overall pain (background pain and paroxysmal pain) on 0-10 numerical scale over the last 48 hours measured three times a week during the follow up of the patient
Secondary Outcome Measures
Full Information
NCT ID
NCT04748484
First Posted
January 11, 2021
Last Updated
February 6, 2021
Sponsor
Gregand Innovations
Collaborators
Clin-Experts
1. Study Identification
Unique Protocol Identification Number
NCT04748484
Brief Title
Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)
Acronym
KCC
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gregand Innovations
Collaborators
Clin-Experts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 and to precise and effective treatments (amputation neuroma pains, for example), whether they are etiological or symptomatic. Other pains of a neuropathic character remain totally or partially resistant to symptomatic treatment. Their appearance, intensity, duration and frequency vary depending on the amputee.
Old scientific data confirmed by modern imagery indicates a process of reorganization of cortical areas by multimodal afferents. This reconstruction, coherent or not of the body diagram, is at the genesis of sensations, normal or not, in the amputee.
Early plurimodal reassignment constitutes the founding principle of the rehabilitation of amputees: tactile afferents, visual afferents, motor afferents, proprioceptive afferents. Rehabilitation techniques and early fitting contribute to this reafferentation and to the functional integration of the fitting and to the quality of life of the amputee.
Scientific work by Katz et al, and experiences of amputees relieved by the application of local heat or stay in hot climatic zones show that the thermoregulation of the residual limb could be of interest.
It has been shown that these pain conditions are often related to a reduction in superficial blood flow to the distal part of the stump. The physiological response of the body to variations in outside temperature physiologically consists in the regulation of skin temperature. The goal seems to keep the body in a so-called "thermal neutrality" zone, substantially between 30 ° C and 33 ° C, by vasodilation or vasoconstriction of the superficial blood vessels depending on exposure to cold or heat.
An innovative medical device has been developed for a regulated thermal re-afferentation of the residual limb, during and outside the wearing of the prosthesis. The Connected Caloprosthesis Kit (CCK®) includes a connected sleeve put in place when wearing the prosthesis (interface between the skin and the socket) and a connected sock to put in place outside of wearing the prosthesis. These 2 devices include an autonomous heating and regulation process, which maintains the amputation stump in the area known as "skin thermal normality". This device is non-invasive. It includes a silicone sleeve and a heating sock for femoral or tibial amputee patients equipped with an expandable textile warmer, a flexible micro-temperature sensor and a 4-conductor extensible cable connected to a thermoregulation box worn as a belt which regulates the temperature of the stumps in the thermal neutrality zone between 30 and 33°C.
In order to assess the therapeutic effect of CCK®, given the heterogeneity of the population and the small number of patients eligible for the study, the Single Case Experimental Design (multiple baselines design) seems to us to be the methodology the most suitable: the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator. The methodology is defined a priori including systematic observations and repeated measurements at a defined frequency before, during, or even after the intervention introduced in a sequential and randomized manner. The data analysis can be individual and therefore patient-specific, but also group with the calculation of the size of the therapeutic effect and the calculation of significance.
This design therefore makes it possible to overcome the difficulties encountered during randomized controlled trials: having to have a large number of subjects necessary to show a significant difference in the medical device and to have a homogeneous population.
This methodology is therefore not a description of a clinical case but an alternative methodology to randomized controlled trials. In fact, it is considered by the Oxford Center for Evidence-Based Medicine 2011 to be level I, like the randomized controlled trials.
The proposed clinical study therefore has a dual objective: practical as a new treatment therapy by validating this medical device and theoretical, supporting the pathogenic model of painful sensations in amputees
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Phantom Limb Pain
Keywords
phantom limb pain, SCED, medical device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case experimental design : the principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator
Masking
None (Open Label)
Masking Description
The medical device will be active or inactive, but the patient nor the investigator won't know if the medical device is active or not. The battery charge indicator will work the same whether the device is operating or not.
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KCC active or inactive
Arm Type
Other
Arm Description
The medical device KCC will be active, or inactive. Randomization will define when and how long time the medical device will be active, and when and how long time the medical device will be inactive. The patient won't know if the medical device is active or not. The battery charge indicator will work the same whether the device is operating or not.
Intervention Type
Device
Intervention Name(s)
KCC Active or inactive
Intervention Description
Depending of the randomization, the KCC will be active or inactive, and will provide heat when active, but the patient won't know if the medical device is active or not. The battery charge indicator will work the same whether the device is operating or not.
Primary Outcome Measure Information:
Title
Intensity of the overall pain (background pain and paroxysmal pain) on 0-10 numerical scale
Description
The primary judgment criteria will be the evaluation of the intensity of the overall pain (background pain and paroxysmal pain) on 0-10 numerical scale over the last 48 hours measured three times a week during the follow up of the patient
Time Frame
Up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RENAUD URBINELLI
Phone
+33658687286
Email
contact@clin-experts.fr
Facility Information:
Facility Name
Hôpital d'Instruction des Armées Percy -
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIE THOMAS-POHL
Phone
+33146321214
First Name & Middle Initial & Last Name & Degree
MARIE THOMAS-POHL
First Name & Middle Initial & Last Name & Degree
LEO BORRINI
Facility Name
Irr Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ISABELLE LOIRET
Phone
+33383529700
First Name & Middle Initial & Last Name & Degree
ISABELLE LOIRET
Facility Name
CRF La Tourmaline
City
Saint-Herblain
ZIP/Postal Code
44818
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUILLAUME BOKOBZA
Phone
+33240385962
Facility Name
Institut Universitaire de Réadaptation Clemenceau
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MATHIEU BERTHEL
Phone
+33388211622
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Evaluation of the Medical Device (MD) (Caloprothese Connected Kit, CCK)
We'll reach out to this number within 24 hrs