The CareFUL Prevention Trial

NCT ID: NCT00803608

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Plantar Ulcer; Diabetes; Neuropathy Causing Loss of Protective Sensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

02

Current standard of care insole

Group Type: ACTIVE_COMPARATOR

Current standard of care insole

Intervention Type: DEVICE

Current Medicare approved A5513 insole

01

TrueContour® insole

Group Type: EXPERIMENTAL

TrueContour® Insole

Intervention Type: DEVICE

Novel designed insole

Interventions

TrueContour® Insole

Novel designed insole

Intervention Type: DEVICE

Current standard of care insole

Current Medicare approved A5513 insole

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

DIApedia, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph L Loomis, MS

Role: PRINCIPAL_INVESTIGATOR

DIApedia, LLC

Locations

Carl T Hayden VA Medical Center

Phoenix, Arizona, United States

Southern Arizona Limb Salvage Alliance

Tucson, Arizona, United States

Center for Clinical Research, Inc

Castro Valley, California, United States

Innovative Medical Technologies

Los Angeles, 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

Cleveland Clinic Foundation

Cleveland, Ohio, 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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24760263 (View on PubMed)

Other Identifiers

R44DK059074

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK05907405A1

Identifier Type: -

Identifier Source: org_study_id