NCT04750876 Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients
| NCT ID | NCT04750876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Departemental Vendee |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-08 |
| Primary Completion | 2027-04-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-04-08 with a primary completion date of 2027-04-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency. As paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations. Following this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.
Eligibility Criteria
Inclusion Criteria: * Patient over the age of majority, no age limit * Amputation related to obliterative arteriopathy of the lower limbs * Trans-tibial or trans-femoral amputation * Patient with an indication of discharge to a rehabilitation and re-education service * Patient with the ability to understand the protocol * Patient who has agreed to participate in the study and has given express oral consent * Patient receiving social security cover or entitled to it Exclusion Criteria: * Trauma related amputation * Amputation of upper limb, trans-metatarsal or one or more toes * Amputation of comfort in a palliative care setting * Patient leaving home after surgery * Patient undergoing psychological or psychiatric treatment * Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception * Patient unable to follow the protocol as judged by the investigator * Patient participating in another interventional research protocol involving a drug or medical device * Patient under guardianship, curators or legal protection measure
Contact & Investigator
Nathalie CORDON
PRINCIPAL INVESTIGATOR
Departmental Hospital Centre - Vendee
Frequently Asked Questions
Who can join the NCT04750876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04750876 currently recruiting?
Yes, NCT04750876 is actively recruiting participants. Contact the research team at promotion.urc@ght85.fr for enrollment information.
Where is the NCT04750876 trial being conducted?
This trial is being conducted at La Roche-sur-Yon, France.
Who is sponsoring the NCT04750876 clinical trial?
NCT04750876 is sponsored by Centre Hospitalier Departemental Vendee. The principal investigator is Nathalie CORDON at Departmental Hospital Centre - Vendee. The trial plans to enroll 40 participants.