Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Healing After Amputation of the Leg (NIRS)

February 5, 2026 updated by: Centre Hospitalier Universitaire Dijon

Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Microcirculation Following Trans-tibial Amputation for Peripheral Artery Disease

50 patients will be included for each of the 2 procedures:

- For procedure 1: Patients will be selected during multidisciplinary consultations for amputees who are stabilized with their definitive prosthesis and have returned to their usual place of residence. The aim of this procedure is to show the validity and reproducibility of measurements of tissue oxygenation using NIRS (TcPO2 being the reference measurement), to determine the way in which NIRS measurements are more precise (i.e. in terms of validity and reproductibility) (values at rest with the patient lying perfectly flat or with the amputated limb raised 30°). These patients will require a single visit which will include measurements by NIRS and TCPO2, a walk test and the completion of 2 questionnaires (visual scale).

- For procedure 2: The patients will be included in the initial phase of postamputation rehabilitation, during the period of in-hospital rehabilitation. The main problems of healing and tolerance to the temporary prosthesis arise during this phase. The specific objectives will be: To show that measurement by NIRS predicts the quality of healing in trans-tibial amputees; to show that the zone of uncertainty concerning the predictive values for the viability of the stump is smaller with NIRS than with TcPO2 (better discrimination). NIRS and TCPO2 measurements as well as the evaluation of stump healing will be done 15, 30 and 45 days after the amputation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All groups:

  • Patients who have agreed to take part in the study
  • Patients with National Health Insurance cover,
  • Patients (men or women aged between 18 and 85 years, presenting unilateral transtibial amputation for PAD.
  • Able to understand simple instructions

Procedure 1:

  • Stabilized patients with their definitive prosthesis, with no modification of the prosthesis in the previous 3 months and at least 6 months after the amputation.
  • Definitive prosthesis with a contact socket.
  • Patients able to do a 2-minute walk test.

Procedure 2:

- Patients in the initial phase of post-amputation (temporary prosthesis, rehabilitation) following unilateral transtibial amputation.

Exclusion Criteria:

  • Patients without national health insurance cover.
  • Patients under guardianship.
  • Patients with associated chronic motor deficiency, of a neurological origin (examples: sequelae of stroke, balance and coordination disorders), or osteo-articular disease (examples: knee or hip osteoarthritis), given their secondary functional impact, making it impossible for amputees to walk with a prosthesis.
  • Severe medical disorder that significantly impairs functional abilities (severe heart failure, respiratory failure, non-stabilized metabolic disorders, such as progressive kidney failure) and diseases with an impact on short or medium-term survival (progressive neoplastic disease, non-stabilized systemic disease).
  • Complications, other than microcirculatory, with the stump, able to affect the use of a contact socket: hematoma, formation of cysts, fluid build-up, calcifications of soft tissues, bone spur, infection (skin, abscess), neurinoma, deterioration of the knee joint of the amputated limb, angle of the tibial cut leading to specifically painful osteo-cutaneous impingement, venous thrombosis, abnormal shape of the stump making it unsuitable for a socket (flexum of the knee, "pear shaped" stumps or stumps with severe invaginations )…
  • Local skin disorders in the measurement zone (summit of the antero-external area) of the stump compromising the quality of the signals picked up by the electrode (NIRS and TcPO2) : severe edema, hyperkeratosis, ulceration, inflammatory and infectious phenomena.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procedure 1
Measures with 60 minutes interval during the consultation of equipment, functional testing, receuil pain.
Device: Measurements using NIRS
Device: TCPO2 measurements
Other: 2-minute walk test
Experimental: Procedure 2
Measuring J15, J30 J 45 and after the different settings functional amputation, pain and tissue oxygenation.
Device: Measurements using NIRS
Device: TCPO2 measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
For procedure 1: the intra-class correlation coefficient between two successive NIRS measurements.
Time Frame: Baseline
Baseline
For procedure 1: the Cronbach alpha coefficient between the NIRS and TcPO2 measurements (the latter being the gold standard).
Time Frame: Baseline
Baseline
For procedure 2: NIRS values at the first consultation and the time to complete healing.
Time Frame: Up to 60 days
Up to 60 days
Procedure 2: NIRS values measured at different sessions and the associated healing evaluation.
Time Frame: 45 days after the amputation
45 days after the amputation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2013

Primary Completion (Actual)

November 16, 2018

Study Completion (Actual)

November 16, 2018

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimated)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CASILLAS Fd. Avenir 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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