ClinicalTrials.Veeva

Menu

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

C

Centre Hospitalier Departemental Vendee

Status

Enrolling

Conditions

Amputation

Treatments

Other: Specific care, including the intervention of a psychologist and a physical therapist.
Other: Conventional support

Study type

Interventional

Funder types

Other

Identifiers

NCT04750876
CHD20_0056

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 in an already amputated patient
  • 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
  • Patient with no history of 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Conventional support
Active Comparator group
Treatment:
Other: Conventional support
Specific care, including the intervention of a psychologist and a physical therapist.
Experimental group
Treatment:
Other: Specific care, including the intervention of a psychologist and a physical therapist.

Trial contacts and locations

1

Loading...

Central trial contact

Laura SOULARD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems