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

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 Overview

• Status: Completed
• Conditions: Diabetes; Plantar Ulcer; Neuropathy Causing Loss of Protective Sensation
• Intervention / Treatment: Device: Current standard of care insole; Device: TrueContour® Insole

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Carl T Hayden VA Medical Center
    • Tucson, Arizona, United States, 85711
      • Southern Arizona Limb Salvage Alliance
  • California
    • Castro Valley, California, United States, 94546
      • Center for Clinical Research, INC
    • Los Angeles, California, United States, 90024
      • Innovative Medical Technologies
  • Colorado
    • Denver, Colorado, United States, 80220
      • Diabetic Foot and Wound Center
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Weil Foot & Ankle Institute
    • Hines, Illinois, United States, 60141
      • Hines VA Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44193
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Blair Medical Associates, Inc
    • Philadelphia, Pennsylvania, United States, 19107
      • Temple University School of Podiatric Medicine
  • Texas
    • McAllen, Texas, United States, 78501
      • Complete Family Footcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 02; Current standard of care insole	Device: Current standard of care insole; Current Medicare approved A5513 insole
Experimental: 01; TrueContour® insole	Device: TrueContour® Insole; Novel designed insole

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DIApedia, LLC
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Joseph L Loomis, MS, DIApedia, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Ulcer; Plantar
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Leg Ulcer; Skin Ulcer; Foot Diseases; Foot Ulcer; Ulcer
• Other Study ID Numbers: DK05907405A1; R44DK059074 (U.S. NIH Grant/Contract)