Diabetes Mellitus, Diabetic Neuropathies, Foot Complications
Conditions
Keywords
Diabetes Mellitus, Diabetic Foot, Diabetic Peripheral Neuropathy, Diabetic Foot Education
Brief 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.
Detailed description
Using block randomization, subjects with diabetes were assigned to either the standard or the enhanced education group. The effectiveness of enhanced education was evaluated as measured by foot care behavior score, patient's interpretation of neuropathy scores, and the incidence of diabetic foot complications over a course of 1-year.
Interventions
BEHAVIORALEnhanced foot care education
In addition to the standard foot care education, personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
BEHAVIORALStandard Foot Care Education
At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Care Behavior Score | baseline, 1, 3,6,9 and 12 months | Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily |
| Patient Interpretation of Neuropathy (PIN) Questionnaire | Baseline, months 1, 3, 6, and 12. | Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot Complications | 1 year | Number of participants with foot complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Foot Care Education Standard Foot Care Education: At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams. | 48 |
| Enhanced Foot Care Education In addition to the standard diabetic foot educational brochure, the importance of daily foot self-care was reinforced by viewing personal barefoot plantar pressure
Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated at baseline visit. Investigator explained how excessive barefoot pressure can lead to skin breakdown and ulcer formation. The education also highlights the benefit of proper footwear and self-foot care measures to prevent injury and complications. | 51 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 19 |
Baseline characteristics
| Characteristic | Standard Foot Care Education | Enhanced Foot Care Education | Total |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 9.5 | 55.9 years STANDARD_DEVIATION 10.2 | 54.5 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 48 participants | 51 participants | 99 participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 30 Participants | 31 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 51 |
| other Total, other adverse events | 21 / 48 | 30 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 51 |
Outcome results
Primary
Foot Care Behavior Score
Daily foot inspection - number (& % of participants) of participants who inspect their feet at least daily
Time frame: baseline, 1, 3,6,9 and 12 months
Population: Fewer participants at follow up visits due to drop out
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baseline | 29 Participants |
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 1 | 33 Participants |
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 3 | 27 Participants |
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 6 | 24 Participants |
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 9 | 19 Participants |
| Standard Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 12 | 14 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 9 | 31 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baseline | 36 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 6 | 35 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 1 | 42 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 12 | 19 Participants |
| Enhanced Foot Care Education | Foot Care Behavior Score | daily foot inspection_baselinescore_month 3 | 40 Participants |
Comparison: A mixed-effect model with repeated measures is used to compare the difference of group over time.p-value: 0.077ANCOVA
Primary
Patient Interpretation of Neuropathy (PIN) Questionnaire
Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)
Time frame: Baseline, months 1, 3, 6, and 12.
Population: Fewer participants in follow up visits due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 3 | 3.77 score on a scale | Standard Deviation 0.76 |
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 1 | 3.86 score on a scale | Standard Deviation 0.7 |
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 6 | 3.63 score on a scale | Standard Deviation 0.84 |
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 9 | 3.83 score on a scale | Standard Deviation 0.69 |
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 12 | 3.71 score on a scale | Standard Deviation 0.73 |
| Standard Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, baseline | 3.86 score on a scale | Standard Deviation 0.66 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 12 | 3.91 score on a scale | Standard Deviation 0.52 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, baseline | 3.86 score on a scale | Standard Deviation 0.68 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 9 | 3.96 score on a scale | Standard Deviation 0.61 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 3 | 3.95 score on a scale | Standard Deviation 0.77 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 1 | 3.83 score on a scale | Standard Deviation 0.8 |
| Enhanced Foot Care Education | Patient Interpretation of Neuropathy (PIN) Questionnaire | id2, month 6 | 3.87 score on a scale | Standard Deviation 0.7 |
p-value: 0.6638Mixed Models Analysis
Secondary
Foot Complications
Number of participants with foot complications
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Foot Care Education | Foot Complications | foot ulcer | 3 Participants |
| Standard Foot Care Education | Foot Complications | subungual hematoma | 13 Participants |
| Standard Foot Care Education | Foot Complications | pre-ulcerative lesions | 7 Participants |
| Enhanced Foot Care Education | Foot Complications | pre-ulcerative lesions | 11 Participants |
| Enhanced Foot Care Education | Foot Complications | foot ulcer | 3 Participants |
| Enhanced Foot Care Education | Foot Complications | subungual hematoma | 6 Participants |
p-value: <0.05ANOVA