Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients (EPKIVA)

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation
• Intervention / Treatment: Other: Conventional support; Other: Specific care, including the intervention of a psychologist and a physical therapist.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura SOULARD; Phone Number: +33 02 51 08 05 82; Email: promotion.urc@ght85.fr

Study Locations

• France
  • La Roche-sur-Yon, France
    • Recruiting
    • Departmental Hospital Centre - Vendee
    • Principal Investigator: Nathalie CORDON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional support	Other: Conventional support; Patients in the "Conventional support" randomisation arm will follow the usual care of amputee patients in the vascular surgery department. They will be cared for by the surgeon, nurses and nursing auxiliaries, who will provide individualised care (nursing care, mobilisation, pain management, technical care, etc.), listening and support.
Experimental: Specific care, including the intervention of a psychologist and a physical therapist.	Other: Specific care, including the intervention of a psychologist and a physical therapist.; In the case where the patient is in the "Specific care, including the intervention of a psychologist and a physical therapist." arm, the usual care will be associated with : consultations with a psychologist; The patient will also be cared for on a daily basis by a physical therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the relevance of the intervention of a physical therapist and a psychologist in the management of amputee patients in vascular surgery at 10 days post-operatively.	Mobility" and "Emotional Reactions" scores collected from the Nottingham Health Profile (NHP) scale at 10 days post-operatively It is a self-questionnaire for measuring perceived health in the general population or in patients. It allows the measurement of health-related quality of life. It is in the form of a questionnaire with 38 questions to which the patient must answer "yes" or "no". A score of 1 point will be awarded for a positive answer and 0 points for a negative answer. A score between 0 and 100 is thus obtained for each patient for each item. This percentage corresponds to the degree of difficulty perceived by the subject in the area of each of the headings.	at 10 days post-operatively

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Nathalie CORDON, Departmental Hospital Centre - Vendee

Publications and helpful links

General Publications

• B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): October 18, 2027

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CHD20_0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No