Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
Primary Purpose
Diabetic Foot, Neuropathy, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Custom made insoles 35 shore
Prefabricated insoles
55 shore Custom made insole
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Foot focused on measuring Diabetic foot, Offloading, Prevention, Orthotics
Eligibility 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
Sites / Locations
- Lundbergs Laboratory for Orthopaedic Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Prefabricated insoles
Custom made insoles 35 shore
55 shore Custom made insoles
Arm Description
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
Outcomes
Primary Outcome Measures
In shoe plantar pressure measurement
Secondary Outcome Measures
Gait analysis
Optical tracking system with skin-mounted markers
Full Information
NCT ID
NCT01663519
First Posted
August 9, 2012
Last Updated
July 25, 2019
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01663519
Brief Title
Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
Official Title
Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Neuropathy, Quality of Life
Keywords
Diabetic foot, Offloading, Prevention, Orthotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prefabricated insoles
Arm Type
Experimental
Arm Description
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Arm Title
Custom made insoles 35 shore
Arm Type
Experimental
Arm Description
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
Arm Title
55 shore Custom made insoles
Arm Type
Experimental
Arm Description
Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
Intervention Type
Other
Intervention Name(s)
Custom made insoles 35 shore
Intervention Description
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Intervention Type
Other
Intervention Name(s)
Prefabricated insoles
Other Intervention Name(s)
Bauerfeind GloboTec® 312750501400
Intervention Description
Prefabricated insoles
Intervention Type
Other
Intervention Name(s)
55 shore Custom made insole
Intervention Description
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Primary Outcome Measure Information:
Title
In shoe plantar pressure measurement
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Gait analysis
Description
Optical tracking system with skin-mounted markers
Time Frame
every 6 months until 24 months is reached
Other Pre-specified Outcome Measures:
Title
Health related quality of life
Time Frame
every 6 months until 24 months is reached
Title
Cost and cost analysis
Description
Calculation of costs for orthopaedic appliance in studied population
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Tranberg, PhD
Organizational Affiliation
Lundbergs laboratory for Orthopaedic Research
Official's Role
Study Chair
Facility Information:
Facility Name
Lundbergs Laboratory for Orthopaedic Research
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29159093
Citation
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.
Results Reference
result
PubMed Identifier
26087865
Citation
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.
Results Reference
result
Links:
URL
http://hdl.handle.net/2077/50860
Description
The Diabetic Foot - assessment and assistive devices
Learn more about this trial
Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
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