Diabetic FootNCT01663519
Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
A study testing Custom made insoles 35 shore, Prefabricated insoles and 55 shore Custom made insole in people with Diabetic Foot and Neuropathy, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Neuropathy, Quality of Life
- What is being tested?
- Custom made insoles 35 shore, Prefabricated insoles and 55 shore Custom made insole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time visitor to Dept of Prosthetics \& Orthotics
- Diabetes
- Age > 18 year
- Be able to walk independently
- Be able to read and understand Swedish
Who cannot join
- Ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
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.
Read the 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.
- Conditions
- Diabetic Foot, Neuropathy, Quality of Life
- Being tested
- Custom made insoles 35 shore, Prefabricated insoles, 55 shore Custom made insole
- Keywords
- Diabetic foot, Offloading, Prevention, Orthotics
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made insoles 35 shoreOther
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Prefabricated insolesOther
Also called Bauerfeind GloboTec® 312750501400
Prefabricated insoles
55 shore Custom made insoleOther
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated insoles | Experimental | Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. Receives: Other: Prefabricated insoles |
| Custom made insoles 35 shore | Experimental | Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate Receives: Other: Custom made insoles 35 shore |
| 55 shore Custom made insoles | Experimental | Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate Receives: Other: 55 shore Custom made insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
In shoe plantar pressure measurement
Measured: up to 24 months
Secondary outcomes (1)
Gait analysis
Optical tracking system with skin-mounted markers
Measured: every 6 months until 24 months is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJan 2008
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Hellstrand Tang, Sahlgrenska University Hospital
- Investigators
- Roy Tranberg, PhD, Study chair, Lundbergs laboratory for Orthopaedic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663519
- Sponsor's protocol ID
- VGFOUGSB-9725 Regional R&D
- Status last verified
- Jul 2019
- First submitted
- 9 Aug 2012
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29159093Tang 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.
PubMed 26087865
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
- ClinicalTrials.gov ID
- NCT01663519
- Acronym / sponsor ID
- VGFOUGSB-9725 Regional R&D
- Conditions
- Diabetic Foot, Neuropathy, Quality of Life
- Keywords
- Diabetic foot, Offloading, Prevention, Orthotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prefabricated insoles | Experimental | Other: Prefabricated insolesPrefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. |
| Custom made insoles 35 shore | Experimental | Other: Custom made insoles 35 shoreCustom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate |
| 55 shore Custom made insoles | Experimental | Other: 55 shore Custom made insoleCustom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First time visitor to Dept of Prosthetics \& Orthotics
- Diabetes
- Age > 18 year
- Be able to walk independently
- Be able to read and understand Swedish
Key exclusion criteria (1 listed)
- Ulcers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom made insoles 35 shoreInsoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast. | Other | Custom made insoles 35 shore |
| Prefabricated insolesAlso: Bauerfeind GloboTec® 312750501400Prefabricated insoles | Other | Prefabricated insoles |
| 55 shore Custom made insoleInsoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast. | Other | 55 shore Custom made insoles |
Primary outcome
In shoe plantar pressure measurement
Time frame: up to 24 months
1 secondary outcome
Gait analysis
Time frame: every 6 months until 24 months is reached
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Results publication: PubMed 29159093Hellstrand 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 publication: PubMed 26087865Tang 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.
- The Diabetic Foot - assessment and assistive devicesLink provided by the sponsor.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Tranberg, PhD study chair
Lundbergs laboratory for Orthopaedic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom made insoles 35 shore, Prefabricated insoles and 55 shore Custom made insole in people with Diabetic Foot and Neuropathy, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In shoe plantar pressure measurement (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01663519, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.