The CareFUL Prevention Trial
Public ClinicalTrials.gov record NCT00803608. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH 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 MTH foot ulcer (\>1 week but \<12 weeks since heeling) and have Loss of Protective Sensation.
Study identification
- NCT ID
- NCT00803608
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 130 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Aug 13, 2014
2009 – 2013
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Carl T Hayden VA Medical Center | Phoenix | Arizona | 85012 | — |
| Southern Arizona Limb Salvage Alliance | Tucson | Arizona | 85711 | — |
| Center for Clinical Research, Inc | Castro Valley | California | 94546 | — |
| Innovative Medical Technologies | Los Angeles | California | 90024 | — |
| Diabetic Foot and Wound Center | Denver | Colorado | 80220 | — |
| Weil Foot & Ankle Institute | Des Plaines | Illinois | 60016 | — |
| Hines VA Hospital | Hines | Illinois | 60141 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44193 | — |
| Blair Medical Associates, Inc | Altoona | Pennsylvania | 16602 | — |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Complete Family Footcare | McAllen | Texas | 78501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00803608, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00803608 live on ClinicalTrials.gov.