Clinical trial NCT00803608: The CareFUL Prevention Trial
Official title: Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plantar Ulcer
Diabetes
Neuropathy Causing Loss of Protective Sensation
Keywords: Plantar
Ulcer
Diabetes
Lead sponsor: DIApedia, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-12-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Men and women, 18 years of age or older at the time of consent;
2. Clinical diagnosis of Diabetes Mellitus ;
3. 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;
4. Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus \>450 kPa;
5. Loss of Protective Sensation (refer to Section 7.2.6);
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;
7. Ability to give consent;
8. 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.

Exclusion Criteria:

1. Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
2. 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;
3. 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);
4. 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;
5. 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;
6. 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;
7. 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
8. Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
9. Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
10. 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.

Primary outcomes:
measure: The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
timeFrame: every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T Hayden VA Medical Center
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Limb Salvage Alliance
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc
state: California
city: Los Angeles
country: United States
facility: Innovative Medical Technologies
state: California
city: Denver
country: United States
facility: Diabetic Foot and Wound Center
state: Colorado
city: Des Plaines
country: United States
facility: Weil Foot & Ankle Institute
state: Illinois
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Altoona
country: United States
facility: Blair Medical Associates, Inc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
city: McAllen
country: United States
facility: Complete Family Footcare
state: Texas
Study officials:
affiliation: DIApedia, LLC
name: Joseph L Loomis, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.