- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499356
Shear and Pressure Reducing Insoles for the Diabetic Foot (GlideSoft)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- To evaluate the efficacy of a shear reducing shoe insole (GlideSoft) in reducing the incidence of diabetic foot pathology among high-risk patients. We studied the effectiveness of a shear reducing shoe insole to prevent foot ulcers in high-risk diabetics with sensory neuropathy, a history of a foot ulcer or a history of a partial foot amputation. The study comprised two treatment arms. The first group received standard therapy involving standard therapeutic shoes and insoles, patient education and regular foot evaluations by a physician. The second group received the same standard therapy, but instead of the standard insoles patients used the GlideSoft - a novel shear reducing insole. As determined in the Phase I study, the GlideSoft dramatically reduced shear forces compared to standard insoles, while performing equally well in reducing compressive forces. Patients were followed for 18 months. The primary study outcome was for incident foot ulcers. Our hypothesis was that patients who use the GlideSoft will have fewer ulcers and that these ulcers will be less severe compared to patients evaluated in the Standard Insole Group.
To evaluate changes in pressure and shear reducing capabilities of the two. To evaluate changes in pressure and shear reducing capabilities of the GlideSoft and standard insoles over the duration of use.
We measured in-shoe pressures and in-vitro shear forces at the foot-insole interface at the beginning of the study and after patients wore the insole for four months or one "standard cycle of wear". We used the Novel Electronics, Inc. Pedar in-shoe pressure system to measure the interface between the foot and insole and the Shear Force Tester (see Phase I report) to evaluate shear forces. We expected that the GlideSoft would significantly reduce shear forces and provide equivalent reduction in vertical forces at both the day 0 evaluation and day 120 evaluations.
- To evaluate patient perceived benefits, satisfaction, and compliance with the 2. To evaluate changes in pressure and shear reducing capabilities of the GlideSoft and standard insoles over the duration of use.
We measured in-shoe pressures and in-vitro shear forces at the foot-insole interface at the beginning of the study and after patients wore the insole for four months or one "standard cycle of wear". We used the Novel Electronics, Inc. Pedar in-shoe pressure system to measure the interface between the foot and insole and the Shear Force Tester (see Phase I report) to evaluate shear forces. We expected that the GlideSoft would significantly reduce shear forces and provide equivalent reduction in vertical forces at both the day 0 evaluation and day 120 evaluations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Kevin R. Higgins, DPM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of diabetes by WHO criteria
- Ability to provide informed consent
- 18-80 years of age
Exclusion Criteria:
- Patients with open ulcers or open amputation sites
- Active Charcot arthropathy
- Severe peripheral vascular disease
- Active foot infection
- Dementia
- Impaired cognitive function
- History of drug or alcohol abuse within one year of the study
- Other conditions based on the PI's clinical judgment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incident foot ulcers
Time Frame: 15 months
|
15 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;30(1):14-20. doi: 10.2337/dc06-1600.
- Lavery LA, LaFontaine J, Higgins KR, Lanctot DR, Constantinides G. Shear-reducing insoles to prevent foot ulceration in high-risk diabetic patients. Adv Skin Wound Care. 2012 Nov;25(11):519-24; quiz 525-6. doi: 10.1097/01.ASW.0000422625.17407.93.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Congenital Abnormalities
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Ulcer
- Lower Extremity Deformities, Congenital
- Diabetic Foot
- Foot Deformities
- Foot Deformities, Congenital
Other Study ID Numbers
- DK55909
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on pressure reducing insole
-
VA Office of Research and DevelopmentRecruitingDiabetesUnited States
-
AO Innovation Translation CenterBerufsgenossenschaftlichen Unfallklinik TuebingenTerminated
-
Staffordshire UniversityKing's College Hospital NHS TrustNot yet recruiting
-
Fondazione Don Carlo Gnocchi OnlusCompletedParkinson DiseaseItaly
-
Rush University Medical CenterArthritis FoundationCompleted
-
University of IowaFoundation for Physical Medicine and RehabilitationCompleted
-
Federal University of São PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedMorton Neuroma
-
Istanbul Medipol University HospitalNot yet recruiting
-
Eastern Mediterranean UniversityHacettepe UniversityCompleted
-
Reckitt Benckiser Healthcare (UK) LimitedSynteractHCR Deutschland GmbHTerminatedMusculoskeletal PainUnited Kingdom