Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prefabricated insoles Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. |
Other: Prefabricated insoles
Prefabricated insoles
Other Names:
|
| Experimental: Custom made insoles 35 shore Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate |
Other: Custom made insoles 35 shore
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
|
| Experimental: 55 shore Custom made insoles Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate |
Other: 55 shore Custom made insole
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
|
Outcome Measures
Primary Outcome Measures
- In shoe plantar pressure measurement [up to 24 months]
Secondary Outcome Measures
- Gait analysis [every 6 months until 24 months is reached]
Optical tracking system with skin-mounted markers
Other Outcome Measures
- Health related quality of life [every 6 months until 24 months is reached]
- Cost and cost analysis [24 month]
Calculation of costs for orthopaedic appliance in studied population
Eligibility Criteria
Criteria
Inclusion criteria:
-
First time visitor to Dept of Prosthetics & Orthotics
-
Diabetes
-
Age > 18 year
-
Be able to walk independently
-
Be able to read and understand Swedish
Exclusion Criteria:
- Ulcers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lundbergs Laboratory for Orthopaedic Research | Gothenburg | Sweden | 413 45 |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
Investigators
- Study Chair: Roy Tranberg, PhD, Lundbergs laboratory for Orthopaedic Research
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- VGFOUGSB-9725 Regional R&D