Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04795271 |
| Other study ID # |
2020/028 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 12, 2020 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
December 2022 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Spain is the country with the second-highest rate of population amputation due to the
development of ulcers, behind the United States, where 2 out of 3 non-traumatic amputations
derive from diabetes. This is why the main objective of this project is to establish a study
protocol for alterations in plantar pressures and gait abnormalities in diabetic patients,
parallel to the preventive orthopedic treatment of major complications such as Charcot's
foot, ulcers in the plantar support surface, and amputations. The study methodology will be
based on the evaluation prior to the personalized orthopedic treatment for each patient and
the evaluation after the orthopedic treatment, specifically at one week, one month, three
months, and six months after the treatment. At each evaluation time, plantar pressure and
reaction forces during walking and local infrared thermography will be analyzed. In the basal
and final evaluation at six months, the muscular strength and range of motion of the lower
limbs will also be evaluated. The orthopedic intervention is personalized to the requirements
of the patients and is based on the use of an insole with the possible inclusion of
orthopedic footwear in order to reduce plantar pressure.
Description:
Background
Diabetic foot is the syndrome characterized by tissue changes (skin, joint, and/or bone) of
the feet of diabetic patients as a result of peripheral neuropathy induced by high glucose
levels, which can be aggravated by the coexistence of microcirculation alterations blood and
whose production involves micro-traumas as a result of support during walking. When tissue
repair or regeneration mechanisms are not effective, these initial lesions can evolve into
ulcerations, superficial and/or deep infections, osteomyelitis or dislocations of the foot
joints (Charcot's foot), with serious consequences for the patient such as limb amputation,
whose costs for Public Health are high. It should be taken into account that Spain is the
country with the second-highest rate of population amputation due to the development of
ulcers, behind the United States, where 2 out of 3 non-traumatic amputations derive from
diabetes.
This is why the main objective of this project is to establish a study protocol for
alterations in plantar pressures and gait abnormalities in diabetic patients, parallel to the
preventive orthopedic treatment of major complications such as Charcot's foot, ulcers in the
plantar support surface, and amputations.
As specific objectives proposed are the following:
1. To evaluate and objectify the clinical and biomechanical alterations of people with
Diabetic foot before orthopedic treatment.
2. To analyze the effects of immediate orthopedic treatment in the medium and long term in
people with Diabetic foot through biomechanical and clinical parameters.
3. To determine if the biomechanical analysis influences the decisions of the trauma
doctors and rehabilitators treating the study participants.
Methodology
1. General organization
The traumatologists (3) and the rehabilitation physician (1) who are part of the
research team of the study will recruit the participants from the medical consultation
that they maintain at the participating hospital in this study. Through compliance with
the inclusion criteria, patients will be invited to enter the study. Those who agree to
participate will sign the corresponding informed consent and will be referred for the
baseline evaluation. The assessment times are as follow:
- Baseline evaluation after signing the informed consent Orthopedic evaluation and
implementation of orthopedic treatment
- Evaluation at one week after starting orthopedic treatment
- Evaluation at one month after starting orthopedic treatment
- Evaluation at three months after starting orthopedic treatment
- Evaluation at six months after starting orthopedic treatment
2. Session assessment
In each of the evaluation sessions mentioned above, the following data and outcomes will be
recorded:
2.1 Clinical assessment: The clinical evaluation will consist of determining the main
anatomical variables that describe the foot of the participants. These variables will be
determined in consultation with a traumatologist or rehabilitation physician at the time of
patient recruitment. It will be determined: a) arch of the foot: this polytomous variable
determines whether the patient has cavus or flat feet; b) Moreau-Costa-Bartani angle (º); c)
Astragalus-calcaneus angle (º); d) Hindfoot alignment: this polytomous variable indicates
whether the patient has a valgus, varus or neutral hindfoot; e) Toe position: this polytomous
variable describes whether the subjects present any of the toes in hyperextension of the
metatarsophalangeal joint with proximal interphalangeal and distal interphalangeal flexion
(claw), or have normal anatomy and position; f) Posterior tibial pulse: explores the
posterior tibial artery, palpated at the ankle at the level of the posterior area of the
external malleolus (internal retro-malleolar canal); g) Pedic pulse: explores the pediatric
artery, palpates at the level of the dorsal aspect of the foot between the extensor tendons
of the 1st and 2nd toes, it can also frequently be palpated between the 2nd and 3rd.
2.2 Anthropometric assessment: A series of essential preliminary measurements will be carried
out for the normalization of biomechanical data and its subsequent comparison between
subjects. The following will be evaluated: a) Weight measurement on the force platform (Kg);
b) Height measurement on stadiometer (Cm); c) Measurement of the arm, leg, and waist contour
measured with a tape measure (Cm); d) Measurement of BMI, body water percentage (%) and body
fat percentage (%) will be extracted with an analytical scale.
2.3 Range of motion assessment: Joint range measurements will be measured with the NeDSGE 4.1
electronic goniometer and NedDiscapacidad / IBV V4.1.1 software (Institute of Biomechanics of
Valencia, Spain) that allows data to be recorded and stored digitally. a) Measurements in the
hip joint: flexion and extension, internal and external rotation, abduction and adduction; b)
Measurements in the knee joint: flexion and extension; c) Measurements in the ankle joint:
dorsal flexion, plantar flexion, inversion, and eversion.
2.4 Muscular strength assessment: To evaluate the degree of muscular force (Newton), an
electronic dynamometer NedDFM/IBV and software NedDiscapacidad/IBV V4.1.1 will be used
(Institute of Biomechanics of Valencia, Spain), which allows the evaluation and recording of
muscular force performed digitally. Three measurements of maximum strength will be obtained
for each gesture, without these differing by more than 10% from each other. a) Muscle
strength measured from the hip flexors, extensors, abductors, adductors, and internal and
external rotators; b) Measured muscle strength of the knee flexor and extensor muscles; c)
Muscle strength measured from the plantar flexor and dorsiflexor muscles of the foot.
2.5 Assessment of speed and ground reaction forces during walking: During the evaluation, the
patient should walk in a 10-meter long corridor, in a straight line at a comfortable or
self-selected speed. Two dynamometric platforms will be used to record the ground reaction
forces during the tread, and two pairs of infrared sensors to record the speed. The software
we use for this evaluation is AMH / IBV 4.0.4. The outcomes obtained from the gait analysis
are; a) Walking speed (m / s); b) Support time (s): proportion of total time spent during the
support phase. Initiated in the contact of a hindfoot and ending in the detachment of the
toes of the same foot. c) Braking force: minimum registered anterior-posterior ground
reaction force corresponding to heel strike (N), d) Propulsive force: maximum registered
anterior-posterior ground reaction force corresponding to takeoff (N), e) Swing force:
minimum registered vertical ground reaction force occurring during contralateral foot
oscillation (N), f) Push-off force: second highest register of the vertical component of
ground reaction force that occurs between heel-off and toe-off (N).
2.6 Assessment of plantar pressure during standing position and walking: The evaluation of
plantar pressures will be carried out during standing position and walking in a straight line
at a comfortable speed. The measuring instrument consists of instrumented insoles with
pressure sensors, which will go inside the patient's footwear. The software used is the
Biofoot/IBV Version 6b. The corridor to be covered by the patient is 10 meters, on which they
can be recorded in five and six strides according to the different lengths of the
participants' stride. The main outcomes obtained from plantar pressure assessment are: a)
Support time (s): total duration of foot contact with the ground; b) cadence (step / min); c)
Maximum pressure (%): maximum pressure value obtained in the analyzed area; d) Maximum
pressure time (%): moment in the support phase in which the maximum pressure value is
reached, expressed as a percentage of time in relation to the total duration of the footfall;
e) Maximum mean pressure (kpa): Maximum value of the mean pressure of the analyzed area
expressed in kilopascals; f) Maximum time of the average pressure (%): instance of the
support phase in which the maximum of the average pressure occurs, expressed as a percentage
of time in relation to the total duration of the tread; g) Integral of Mean Pressure: area
under the curve described by mean pressure over time.
2.7 Thermographic assessment: Thermographic images were recorded before and after of gait
measurements. Before walking, the change in temperature was also observed when a cold
stimulus was applied to the plantar of both foot. All thermographic images were recorded
digitally by a thermography camera with an infrared resolution of 320×240 pixels, thermal
sensitivity <0.05 °C, and accuracy of ±2 °C (FLIR E60, FLIR, Wilsonville, Oregon, USA). A
black body (BX-500 IR Infrared Calibrator, CEM, Shenzhen, China) was used before the study to
ensure a correct calibration of the camera. The camera was positioned 1 m far from the
subjects and kept perpendicular to body areas of interest. Images were recorded in a
controlled environment (e.g. light and temperature controlled room) with no person (apart
from the infrared operator and the participant) or equipment in a range of 5 m that could
disturbed in the measure. An anti-reflective panel was used behind the participant to
minimize effects from infrared radiation reflected by the participant in the wall. Images
were stored for offline analysis using a commercial software (Thermacam Researcher Pro 2.10
software, FLIR, Wilsonville, Oregon, USA). All images were processed using an emissivity
factor of 0.98 to obtain skin temperatures, and for all measures, air temperature, humidity,
and reflected temperature were informed in the camera setup using a weather station (Digital
thermo-hygrometer, TFA Dostmann, Wertheim-Reicholzheim, Germany).
