DiabetesPhase 1NCT00240175
Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
A Phase 1 study of Diabetes, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
Foot orthotics or shoe inserts are currently utilized as a common conservative treatment option for a wide variety of foot disorders. This treatment is used for both the relatively healthy active population and the more sedentary population with diabetes or peripheral vascular disease (dysvascular). Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Aug 2011
- Phase
- Phase 1
- 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 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal gait pattern
- Category 1 diabetic rating by the UTHSCSA Podiatry scale - Category 1 diabetics have documentable peripheral neuropathy but no history of foot ulceration.
- males or females between the ages of 18 and 66
Who cannot join
- neuromuscular deficits
- no foot abnormalities (hammer toes, pes cavus) that requires specialized footwear. The participant must be tolerant of the study shoes to be supplied. To address this matter a four week accommodation period to the study shoe will be required for inclusion to the study.
- No pregnant females due to subsequent alterations in gait patterns
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Diabetes Institute
San Antonio, Texas, 78207
South Texas Veterans Healthcare System
San Antonio, Texas, 78229
About this study
Foot orthotics or shoe inserts are currently utilized as a common conservative treatment option for a wide variety of foot disorders. This treatment is used for both the relatively healthy active population and the more sedentary population with diabetes or peripheral vascular disease (dysvascular). However, there is limited objective scientific data documenting the actual benefits or effectiveness of either customized or over-the-counter foot orthoses. It is the aim of this study to determine the effects of three popular foot orthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized as a preventive treatment option to reduce the risk for foot ulceration by redistributing plantar pressures, then orthoses would be a cost effective solution to a high cost (mental and fiscal) medical impairment.
Read the detailed description
It is estimated that over 17 million people are affected with diabetes with more than 8 million remaining undiagnosed in the United States alone. Of the total diabetic population, approximately 15% will develop foot ulcerations with 6% continuing onto some manner of foot or lower limb amputation. While it has been widely recommended that therapeutic shoes and foot orthotics be utilized in the ongoing care of diabetics with insensate feet, there is limited scientific literature quantifying the actual effects. If the early use of orthotic devices is able to decrease the risk or delay the onset of foot ulceration, this could be an essential treatment strategy for individuals with diabetes or peripheral vascular.
To evaluate the orthotic devices a repeated measure within subject study design is purposed. There will be forty two diabetic subjects rated at Category 1 by the UTHSCSA Podiatry Scale (Peripheral neuropathy, no history of ulceration). Each subject will receive three sets of foot orthotics and a pair of extra-depth athletic shoes. The subjects will receive and wear the orthotics in a randomized order. The orthotics to be tested will vary in materials and morphology. They will be a custom molded trilaminar insert, a prefabricated trilaminar insert without any modifications, and an over-the-counter contoured shoe insert of Plastazote and polyurethane. Plantar pressure measurements will be acquired at baseline and after four weeks of accommodation to each set of foot orthoses. It is anticipated that a participant's involvement with the study will require five months.
This study will help to determine the efficacy of the three different types of foot orthotics and help to establish better guidelines for health care practitioners regarding optimal foot care in diabetes and to assist in collecting data for future grants.
- Conditions
- Diabetes
- Being tested
- No Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measures of plantar pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hope S Hacker, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240175
- Sponsor's protocol ID
- 056-0011-010
- Other IDs
- VVISN Project # 0001
- Status last verified
- Feb 2012
- First submitted
- 13 Oct 2005
- Last updated
- 1 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Foot Orthotics on Plantar Pressures in the Diabetic Population
- ClinicalTrials.gov ID
- NCT00240175
- Acronym / sponsor ID
- 056-0011-010
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Oct 2005 (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.
Foot orthotics or shoe inserts are currently utilized as a common conservative treatment option for a wide variety of foot disorders. This treatment is used for both the relatively healthy active population and the more sedentary population with diabetes or peripheral vascular disease (dysvascular). However, there is limited objective scientific data documenting the actual benefits or effectiveness of either customized or over-the-counter foot orthoses. It is the aim of this study to determine the effects of three popular foot orthotics on plantar pressures in diabetic populations. If foot orthoses can be utilized as a preventive treatment option to reduce the risk for foot ulceration by redistributing plantar pressures, then orthoses would be a cost effective solution to a high cost (mental and fiscal) medical impairment.
Detailed description
It is estimated that over 17 million people are affected with diabetes with more than 8 million remaining undiagnosed in the United States alone. Of the total diabetic population, approximately 15% will develop foot ulcerations with 6% continuing onto some manner of foot or lower limb amputation. While it has been widely recommended that therapeutic shoes and foot orthotics be utilized in the ongoing care of diabetics with insensate feet, there is limited scientific literature quantifying the actual effects. If the early use of orthotic devices is able to decrease the risk or delay the onset of foot ulceration, this could be an essential treatment strategy for individuals with diabetes or peripheral vascular.
To evaluate the orthotic devices a repeated measure within subject study design is purposed. There will be forty two diabetic subjects rated at Category 1 by the UTHSCSA Podiatry Scale (Peripheral neuropathy, no history of ulceration). Each subject will receive three sets of foot orthotics and a pair of extra-depth athletic shoes. The subjects will receive and wear the orthotics in a randomized order. The orthotics to be tested will vary in materials and morphology. They will be a custom molded trilaminar insert, a prefabricated trilaminar insert without any modifications, and an over-the-counter contoured shoe insert of Plastazote and polyurethane. Plantar pressure measurements will be acquired at baseline and after four weeks of accommodation to each set of foot orthoses. It is anticipated that a participant's involvement with the study will require five months.
This study will help to determine the efficacy of the three different types of foot orthotics and help to establish better guidelines for health care practitioners regarding optimal foot care in diabetes and to assist in collecting data for future grants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal gait pattern
- Category 1 diabetic rating by the UTHSCSA Podiatry scale - Category 1 diabetics have documentable peripheral neuropathy but no history of foot ulceration.
- males or females between the ages of 18 and 66
Key exclusion criteria (3 listed)
- neuromuscular deficits
- no foot abnormalities (hammer toes, pes cavus) that requires specialized footwear. The participant must be tolerant of the study shoes to be supplied. To address this matter a four week accommodation period to the study shoe will be required for inclusion to the study.
- No pregnant females due to subsequent alterations in gait patterns
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 |
|---|---|---|
| No InterventionNo Intervention | Other | – |
Primary outcome
Quantitative measures of plantar pressure
Time frame: 1 year
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 1 Mar 2012.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Hope S Hacker, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Diabetes, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
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 3 inclusion and 3 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 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantitative measures of plantar pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2012.