External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
NCT ID: NCT04117269
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2019-11-15
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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External shoe lift
Those patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer).
External shoe lift
Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
Standard of care
Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.
No interventions assigned to this group
Interventions
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External shoe lift
Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
Eligibility Criteria
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Inclusion Criteria
* Wagner I and II classification.
* Ulcer area between 1-30 cm square centimeters.
* HbA1c values in the last three months below 11%
* Ankle brachial Index (ABI) value \> 0.5.
Exclusion Criteria
* Presence of foot ulcer in both feet.
* Presence of soft tissue infection.
* Osteomyelitis suspicion.
* Peripheral neuropathy due to different causes than diabetes.
18 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Raúl Juan Molines Barroso, Phd
Clinical Professor
Locations
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Diabetic foot Unit Complutense University
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19/337-E
Identifier Type: -
Identifier Source: org_study_id
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