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The CareFUL Prevention Trial (CareFULPrevent)

Primary Purpose

Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TrueContour® Insole
Current standard of care insole
Sponsored by
DIApedia, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plantar Ulcer focused on measuring Plantar, Ulcer, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carl T Hayden VA Medical Center
  • Southern Arizona Limb Salvage Alliance
  • Center for Clinical Research, Inc
  • Innovative Medical Technologies
  • Diabetic Foot and Wound Center
  • Weil Foot & Ankle Institute
  • Hines VA Hospital
  • Cleveland Clinic Foundation
  • Blair Medical Associates, Inc
  • Temple University School of Podiatric Medicine
  • Complete Family Footcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

02

01

Arm Description

Current standard of care insole

TrueContour® insole

Outcomes

Primary Outcome Measures

The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer

Secondary Outcome Measures

Full Information

First Posted
December 4, 2008
Last Updated
August 12, 2014
Sponsor
DIApedia, LLC
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00803608
Brief Title
The CareFUL Prevention Trial
Acronym
CareFULPrevent
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DIApedia, LLC
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation
Keywords
Plantar, Ulcer, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
02
Arm Type
Active Comparator
Arm Description
Current standard of care insole
Arm Title
01
Arm Type
Experimental
Arm Description
TrueContour® insole
Intervention Type
Device
Intervention Name(s)
TrueContour® Insole
Intervention Description
Novel designed insole
Intervention Type
Device
Intervention Name(s)
Current standard of care insole
Intervention Description
Current Medicare approved A5513 insole
Primary Outcome Measure Information:
Title
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
Time Frame
every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph L Loomis, MS
Organizational Affiliation
DIApedia, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl T Hayden VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Southern Arizona Limb Salvage Alliance
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Center for Clinical Research, Inc
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Innovative Medical Technologies
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Diabetic Foot and Wound Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Weil Foot & Ankle Institute
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Hines VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44193
Country
United States
Facility Name
Blair Medical Associates, Inc
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Temple University School of Podiatric Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Complete Family Footcare
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24760263
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.
Results Reference
derived

Learn more about this trial

The CareFUL Prevention Trial

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