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NCT Number: NCT04750876

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

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.

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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departmental Hospital Centre - Vendee

La Roche-sur-Yon, France

Location status: Recruiting

Location contact

Nathalie CORDON

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional support

Other

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.

Specific care, including the intervention of a psychologist and a physical therapist.

Other

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.

Primary outcomes

  1. 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.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura SOULARD

CONTACT

[email protected]

02 51 08 05 82 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: EPKIVA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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