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

NCT02551484 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-02-09

No results posted yet for this study

Summary

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.

Conditions

  • A Stabilized Definitive Prosthesis (Procedure 1)
  • Definitive Prosthesis With a Contact Socket (Procedure 1)
  • Patients in the Initial Phase (Temporary Prosthesis, Rehabilitation) Following Unilateral Post- Transtibial Amputation (Procedure 2)

Interventions

DEVICE

Measurements using NIRS

DEVICE

TCPO2 measurements

OTHER

2-minute walk test

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-15
Primary Completion
2018-11-16
Completion
2018-11-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551484 on ClinicalTrials.gov