The CareFUL Prevention Trial

Phase 2

Completed

• Conditions: Neuropathy Causing Loss of Protective Sensation; Diabetes; Plantar Ulcer
• Interventions: Device: TrueContour® Insole; Device: Current standard of care insole

• Registration Number: NCT00803608
• Lead Sponsor: DIApedia, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Study Start: 2009-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
01	TrueContour® Insole	TrueContour® insole
02	Current standard of care insole	Current standard of care insole

Primary Outcome Measures

Name	Time	Method
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer	every 3 months

Trial Locations

Locations (11)

Carl T Hayden VA Medical Center; 🇺🇸 Phoenix, Arizona, United States

Innovative Medical Technologies; 🇺🇸 Los Angeles, California, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Southern Arizona Limb Salvage Alliance; 🇺🇸 Tucson, Arizona, United States

Center for Clinical Research, Inc; 🇺🇸 Castro Valley, California, United States

Diabetic Foot and Wound Center; 🇺🇸 Denver, Colorado, United States

Weil Foot & Ankle Institute; 🇺🇸 Des Plaines, Illinois, United States

Hines VA Hospital; 🇺🇸 Hines, Illinois, United States

Blair Medical Associates, Inc; 🇺🇸 Altoona, Pennsylvania, United States

Temple University School of Podiatric Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Complete Family Footcare; 🇺🇸 McAllen, Texas, United States