Diabetic Foot Ulcer, Peripheral Neuropathy, Treatment Adherence and Compliance
Conditions
Brief summary
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
Interventions
DEVICEExternal 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
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plantar diabetic foot ulcer. * 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
* Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline. * Presence of foot ulcer in both feet. * Presence of soft tissue infection. * Osteomyelitis suspicion. * Peripheral neuropathy due to different causes than diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of diabetic foot ulcers healed | 12 weeks | Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of diabetic foot ulcers healed | 20 weeks | Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate |
| Adherence to offloading device | 3 days | Two pedometer will be used (one inside the vendaje and the other into the offloading device) |
| Time to healing | 30 weeks | Time in weeks of diabetic foot ulcer healing |
Countries
Spain
Contacts
Primary ContactRaúl Juan Molines Barroso, Phd
Outcome results
None listed