N/A N=99 Randomized Single-blind Prevention

Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures

Diabetes Mellitus · Diabetic Neuropathies · Foot Complications

Bottom Line

View on ClinicalTrials.gov: NCT01941719 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Foot Care Behavior Score — 29; 36; 33; 42 Participants — p=0.0770

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Enhanced foot care education (Behavioral); Standard Foot Care Education (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Temple University
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Foot Care Behavior Score	29; 36; 33; 42; 27; 40	0.0770
PRIMARY Patient Interpretation of Neuropathy (PIN) Questionnaire	3.86; 3.86; 3.86; 3.83; 3.77; 3.95	0.6638
SECONDARY Foot Complications	7; 11; 3; 3; 13; 6	< 0.05 sig

Summary

The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education. The proposed diabetic foot care education uses personal computer-animated plantar pressure data to educate patients on why and how they should care for their feet.

Eligibility Criteria

Inclusion Criteria

Male or female between the ages of 21 and 75 years (inclusive)
Documented type 1 or type 2 diabetes mellitus
Demonstrates peripheral neuropathy (defined as vibration perception threshold (VPT) ≥ 25 volts at the hallux, as quantified by a BioThesiometer, or unable to perceive a 10 gram Semmes-Weinstein monofilament in one four sites on the feet)
Able to walk independently without the use of walking aids (cane, crutches, or walker)
Able to speak and understand English
Able to understand the information in the informed consent form and willing and able to sign the consent form

Exclusion Criteria

Amputation of either foot proximal to midfoot
Presence of cutaneous ulceration in the lower extremity
History of or active Charcot neuroarthropathy of either foot
Severe peripheral vascular disease (ie. ischemic rest pain, 2-block claudication or gangrene)
End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
Pregnant or nursing
Life expectancy < 12 months
Not willing or able to make the required follow-up visits
Insufficient (corrected) vision to complete the questionnaires

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01941719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.