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Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. Further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this study is to compare three different types of insoles with respect to pressure distribution. Every 6 months follow-up is assessed until 24 months is reached.
Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit.
At deliverance base line measurement was assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prefabricated insoles | Experimental | Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. |
|
| Custom made insoles 35 shore | Experimental | Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate |
|
| 55 shore Custom made insoles | Experimental | Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom made insoles 35 shore | Other | Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| In shoe plantar pressure measurement | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Optical tracking system with skin-mounted markers | every 6 months until 24 months is reached |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | every 6 months until 24 months is reached | |
| Cost and cost analysis | Calculation of costs for orthopaedic appliance in studied population | 24 month |
Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Tranberg, PhD | Lundbergs laboratory for Orthopaedic Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lundbergs Laboratory for Orthopaedic Research | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29159093 | Result | Hellstrand Tang U, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial. J Clin Transl Endocrinol. 2014 Jul 24;1(4):121-132. doi: 10.1016/j.jcte.2014.06.002. eCollection 2014 Dec. | |
| 26087865 |
| Label | URL |
|---|---|
| The Diabetic Foot - assessment and assistive devices | View source |
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| Prefabricated insoles | Other | Prefabricated insoles |
|
|
| 55 shore Custom made insole | Other | Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast. |
|
| Tang UH, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers. Diabet Foot Ankle. 2015 Jun 17;6:27593. doi: 10.3402/dfa.v6.27593. eCollection 2015. |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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