A Stabilized Definitive Prosthesis (Procedure 1)NIRSNCT02551484
Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Healing After Amputation of the Leg
A study testing Measurements using NIRS, TCPO2 measurements and 2-minute walk test in people with A Stabilized Definitive Prosthesis (Procedure 1) and Definitive Prosthesis With a Contact Socket (Procedure 1), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- 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)
- What is being tested?
- Measurements using NIRS, TCPO2 measurements and 2-minute walk test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2013to 16 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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)
- Being tested
- Measurements using NIRS, TCPO2 measurements, 2-minute walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements using NIRSDevice
TCPO2 measurementsDevice
2-minute walk testOther
| Study group | Role | What they receive |
|---|---|---|
| Procedure 1 | Experimental | Measures with 60 minutes interval during the consultation of equipment, functional testing, receuil pain. Receives: Device: Measurements using NIRS; Device: TCPO2 measurements; Other: 2-minute walk test |
| Procedure 2 | Experimental | Measuring J15, J30 J 45 and after the different settings functional amputation, pain and tissue oxygenation. Receives: Device: Measurements using NIRS; Device: TCPO2 measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
For procedure 1: the intra-class correlation coefficient between two successive NIRS measurements.
Measured: Baseline
For procedure 1: the Cronbach alpha coefficient between the NIRS and TcPO2 measurements (the latter being the gold standard).
Measured: Baseline
For procedure 2: NIRS values at the first consultation and the time to complete healing.
Measured: Up to 60 days
Procedure 2: NIRS values measured at different sessions and the associated healing evaluation.
Measured: 45 days after the amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start15 Jan 2013
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Why it stopped: The patient population presenting in the department has evolved and no longer allows for the recruitment of the necessary number of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for A Stabilized Definitive Prosthesis (Procedure 1)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551484
- Sponsor's protocol ID
- CASILLAS Fd. Avenir 2012
- Acronym
- NIRS
- Status last verified
- Feb 2026
- First submitted
- 20 Aug 2015
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Laroche D, Barnay JL, Tourlonias B, Orta C, Obert C, Casillas JM. Microcirculatory Assessment of Arterial Below-Knee Stumps: Near-Infrared Spectroscopy Versus Transcutaneous Oxygen Tension-A Preliminary Study in Prosthesis Users. Arch Phys Med Rehabil. 2017 Jun;98(6):1187-1194. doi: 10.1016/j.apmr.2016.12.001. Epub 2016 Dec 31.
PubMed 28049004
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Near-InfraRed Spectroscopy (NIRS) to the Evaluation of Microcirculation Following Trans-tibial Amputation for Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02551484
- Acronym / sponsor ID
- NIRS / CASILLAS Fd. Avenir 2012
- 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)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient population presenting in the department has evolved and no longer allows for the recruitment of the necessary number of patients.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Jan 2013 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure 1 | Experimental | Device: Measurements using NIRS, Device: TCPO2 measurements, Other: 2-minute walk testMeasures with 60 minutes interval during the consultation of equipment, functional testing, receuil pain. |
| Procedure 2 | Experimental | Device: Measurements using NIRS, Device: TCPO2 measurementsMeasuring J15, J30 J 45 and after the different settings functional amputation, pain and tissue oxygenation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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.
Key exclusion criteria (6 listed)
- 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 )…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements using NIRS | Device | Procedure 1, Procedure 2 |
| TCPO2 measurements | Device | Procedure 1, Procedure 2 |
| 2-minute walk test | Other | Procedure 1 |
Primary outcome
For procedure 1: the intra-class correlation coefficient between two successive NIRS measurements.
Time frame: Baseline
For procedure 1: the Cronbach alpha coefficient between the NIRS and TcPO2 measurements (the latter being the gold standard).
Time frame: Baseline
For procedure 2: NIRS values at the first consultation and the time to complete healing.
Time frame: Up to 60 days
Procedure 2: NIRS values measured at different sessions and the associated healing evaluation.
Time frame: 45 days after the amputation
Results and safety
The study was stopped early (reason given: The patient population presenting in the department has evolved and no longer allows for the recruitment of the necessary number of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 28049004Laroche D, Barnay JL, Tourlonias B, Orta C, Obert C, Casillas JM. Microcirculatory Assessment of Arterial Below-Knee Stumps: Near-Infrared Spectroscopy Versus Transcutaneous Oxygen Tension-A Preliminary Study in Prosthesis Users. Arch Phys Med Rehabil. 2017 Jun;98(6):1187-1194. doi: 10.1016/j.apmr.2016.12.001. Epub 2016 Dec 31.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements using NIRS, TCPO2 measurements and 2-minute walk test in people with A Stabilized Definitive Prosthesis (Procedure 1) and Definitive Prosthesis With a Contact Socket (Procedure 1), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The patient population presenting in the department has evolved and no longer allows for the recruitment of the necessary number of patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For procedure 1: the intra-class correlation coefficient between two successive NIRS measurements. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.