Light-Based device may predict amputation healing
NCT ID NCT02551484
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a device that uses near-infrared light (NIRS) can measure blood flow in the remaining leg after a below-knee amputation better than the standard method (TcPO2). Researchers planned to include 50 patients in two groups: those with a permanent prosthetic leg and those still in early rehabilitation. The goal was to see if NIRS could predict wound healing more accurately. However, the study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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62 people
The number who actually took part.
- Started
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Jan 2013
- Finished
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Nov 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU de DIJON
Dijon, 21079, France
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