The CareFUL Prevention Trial
CareFULPrevent
Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
2 other identifiers
interventional
130
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 13, 2014
August 1, 2014
4.8 years
December 4, 2008
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
every 3 months
Study Arms (2)
02
ACTIVE COMPARATORCurrent standard of care insole
01
EXPERIMENTALTrueContour® insole
Interventions
Eligibility Criteria
You may qualify if:
- Men and women, 18 years of age or older at the time of consent;
- Clinical diagnosis of Diabetes Mellitus ;
- At least one recently healed plantar MTH-related foot ulcer (\>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;
- Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus \>450 kPa;
- Loss of Protective Sensation (refer to Section 7.2.6);
- Community ambulator defined as having the ability or potential for ambulation outside in the community including the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces, or better by subject report;
- Ability to give consent;
- In the opinion of the site PI the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.
You may not qualify if:
- Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
- Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible;
- Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);
- A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, if the associated plantar pressure is \>450kPa
- Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
- Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
- Need for more complex intervention, i.e. the site PI's decision is that the study footwear would not be adequate for the subject's needs, e.g. a rigid outsole or custom molded shoes are deemed necessary.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, 85711, United States
Center for Clinical Research, Inc
Castro Valley, California, 94546, United States
Innovative Medical Technologies
Los Angeles, California, 90024, United States
Diabetic Foot and Wound Center
Denver, Colorado, 80220, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
Hines VA Hospital
Hines, Illinois, 60141, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44193, United States
Blair Medical Associates, Inc
Altoona, Pennsylvania, 16602, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
Complete Family Footcare
McAllen, Texas, 78501, United States
Related Publications (1)
Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23.
PMID: 24760263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph L Loomis, MS
DIApedia, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
February 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 13, 2014
Record last verified: 2014-08