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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00803608 |
To assess the efficacy of TrueContour Insoles versus the current standard of care insoles in recurrence of plantar ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.
Condition | Intervention | Phase |
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Plantar Ulcer Diabetes Loss of Protective Sensation |
Device: True Contour Insole Device: Standard Insole |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention |
Estimated Enrollment: | 286 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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02: Active Comparator
Current standard of care insole
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Device: Standard Insole
Current SADMERC approved insole
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01: Experimental
True Contour insole
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Device: True Contour Insole
Novel designed insole
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alesia N Aileo, BS | 814-234-0700 | aaileo@diapedia.com |
Contact: Marty Bradley | 814-234-0700 | mbradley@diapedia.com |
Principal Investigator: | Joseph L Loomis, MS | DIApedia, LLC |
Responsible Party: | DIApedia, LLC ( Joseph Loomis ) |
Study ID Numbers: | DK05907405A1 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803608 |
Health Authority: | United States: Federal Government |
Plantar Ulcer Diabetes |
Foot Ulcer Skin Diseases Ulcer Diabetes Mellitus |
Skin Ulcer Foot Diseases Leg Ulcer |
Pathologic Processes |