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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External shoe lift | Experimental | 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). |
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| Standard of care | No Intervention | Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External shoe lift | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of diabetic foot ulcers healed | Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of diabetic foot ulcers healed | Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate | 20 weeks |
| Adherence to offloading device | Two pedometer will be used (one inside the vendaje and the other into the offloading device) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl Juan Molines Barroso, Phd | Contact | 639059104 | +34 | rauljmolines@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetic foot Unit Complutense University | Recruiting | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39447017 | Derived | Lopez-Moral M, Garcia-Madrid M, Molines-Barroso RJ, Sanz-Corbalan I, Tardaguila-Garcia A, Lazaro-Martinez JL. Clinical Efficacy of a Contralateral Shoe Lift in Patients with Diabetic Foot Ulcers and Induced Limb-Length Discrepancies: A Randomized Controlled Trial. Adv Wound Care (New Rochelle). 2025 May;14(5):251-259. doi: 10.1089/wound.2024.0151. Epub 2024 Oct 24. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D010523 | Peripheral Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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|
| 3 days |
| Time to healing | Time in weeks of diabetic foot ulcer healing | 30 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |