ClinicalTrials.gg
RecruitingNCT04750876EPKIVAUpdated May 15, 2026

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

An interventional study of Conventional support and Specific care, including the intervention of a psychologist and a physical therapist. in Amputation, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Amputation
03

In context

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Conventional support

    Other: Conventional 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.

Interventions

  • OtherConventional 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.

  • OtherSpecific 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.

06

What researchers measure

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.

    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.

    Time frame: at 10 days post-operatively

07

Study locations

1 of 1 sites recruiting
  • Departmental Hospital Centre - Vendee
    La Roche-sur-Yon, France
    Recruiting
    • Nathalie CORDON · Principal investigator
08

References and documents

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. PubMed 37276273 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04750876
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Feb 11, 2021
Start date
Apr 8, 2021
Primary completion
Apr 18, 2027 (estimated)
Completion
Oct 18, 2027 (estimated)
Last update
May 15, 2026

Study contacts

Laura SOULARD
Contact
promotion.urc@ght85.fr
02 51 08 05 82 ext. +33
Nathalie CORDON
principal investigator · Departmental Hospital Centre - Vendee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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