The CareFUL Prevention Trial

Diabetes Clinical Trial

— CareFULPrevent  

Official title:

Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803608
• Other study ID #: DK05907405A1
• Secondary ID: R44DK059074
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2008
• Last updated: August 12, 2014
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: DIApedia, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Neuropathy Causing Loss of Protective Sensation
• Plantar Ulcer

Intervention

Device:
• TrueContour® Insole
Novel designed insole
• Current standard of care insole
Current Medicare approved A5513 insole

Locations

Country	Name	City	State
United States	Blair Medical Associates, Inc	Altoona	Pennsylvania
United States	Center for Clinical Research, Inc	Castro Valley	California
United States	Cleveland Clinic Foundation	Cleveland	Ohio
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	Innovative Medical Technologies	Los Angeles	California
United States	Complete Family Footcare	McAllen	Texas
United States	Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania
United States	Carl T Hayden VA Medical Center	Phoenix	Arizona
United States	Southern Arizona Limb Salvage Alliance	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
DIApedia, LLC	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer		every 3 months	Yes