Trial Outcomes & Findings for Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures (NCT NCT01941719)
NCT ID: NCT01941719
Last Updated: 2021-12-07
Results Overview
Daily foot inspection - number (\& % of participants) of participants who inspect their feet at least daily
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
baseline, 1, 3,6,9 and 12 months
Results posted on
2021-12-07
Participant Flow
Participant milestones
| Measure |
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). In addition, a 1-page diabetic footwear selection criteria is provided.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
Month 1
|
43
|
48
|
|
Overall Study
Month 3
|
38
|
44
|
|
Overall Study
Month 6
|
34
|
42
|
|
Overall Study
Month 9
|
29
|
37
|
|
Overall Study
Month 12
|
28
|
32
|
|
Overall Study
COMPLETED
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
20
|
19
|
Reasons for withdrawal
| Measure |
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). In addition, a 1-page diabetic footwear selection criteria is provided.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
19
|
Baseline Characteristics
Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
Baseline characteristics by cohort
| Measure |
Standard Foot Care Education
n=48 Participants
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.
|
Enhanced Foot Care Education
n=51 Participants
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.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
51 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 1, 3,6,9 and 12 monthsPopulation: Fewer participants at follow up visits due to drop out
Daily foot inspection - number (\& % of participants) of participants who inspect their feet at least daily
Outcome measures
| Measure |
Standard Foot Care Education
n=48 Participants
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). Also, a 1-page supplementary diabetic footwear educational material was reviewed. The aims of education are to emphasize the importance of checking feet daily, highlighting diabetic foot complications that can arise from repetitive trauma and inappropriate footwear in the absence of protective sensation.
|
Enhanced Foot Care Education
n=51 Participants
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.
|
|---|---|---|
|
Foot Care Behavior Score
daily foot inspection_baseline
|
29 Participants
|
36 Participants
|
|
Foot Care Behavior Score
daily foot inspection_baselinescore_month 1
|
33 Participants
|
42 Participants
|
|
Foot Care Behavior Score
daily foot inspection_baselinescore_month 3
|
27 Participants
|
40 Participants
|
|
Foot Care Behavior Score
daily foot inspection_baselinescore_month 6
|
24 Participants
|
35 Participants
|
|
Foot Care Behavior Score
daily foot inspection_baselinescore_month 9
|
19 Participants
|
31 Participants
|
|
Foot Care Behavior Score
daily foot inspection_baselinescore_month 12
|
14 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Baseline, months 1, 3, 6, and 12.Population: Fewer participants in follow up visits due to drop out
Participants who demonstrated an accurate interpretation of diabetic peripheral neuropathy (id2). The score range from 1 (correct interpretation) to 5 (misinterpretation)
Outcome measures
| Measure |
Standard Foot Care Education
n=48 Participants
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). Also, a 1-page supplementary diabetic footwear educational material was reviewed. The aims of education are to emphasize the importance of checking feet daily, highlighting diabetic foot complications that can arise from repetitive trauma and inappropriate footwear in the absence of protective sensation.
|
Enhanced Foot Care Education
n=51 Participants
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.
|
|---|---|---|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, month 1
|
3.86 score on a scale
Standard Deviation 0.70
|
3.83 score on a scale
Standard Deviation 0.80
|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, month 3
|
3.77 score on a scale
Standard Deviation 0.76
|
3.95 score on a scale
Standard Deviation 0.77
|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, month 6
|
3.63 score on a scale
Standard Deviation 0.84
|
3.87 score on a scale
Standard Deviation 0.70
|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, month 9
|
3.83 score on a scale
Standard Deviation 0.69
|
3.96 score on a scale
Standard Deviation 0.61
|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, month 12
|
3.71 score on a scale
Standard Deviation 0.73
|
3.91 score on a scale
Standard Deviation 0.52
|
|
Patient Interpretation of Neuropathy (PIN) Questionnaire
id2, baseline
|
3.86 score on a scale
Standard Deviation 0.66
|
3.86 score on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants with foot complications
Outcome measures
| Measure |
Standard Foot Care Education
n=48 Participants
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). Also, a 1-page supplementary diabetic footwear educational material was reviewed. The aims of education are to emphasize the importance of checking feet daily, highlighting diabetic foot complications that can arise from repetitive trauma and inappropriate footwear in the absence of protective sensation.
|
Enhanced Foot Care Education
n=51 Participants
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.
|
|---|---|---|
|
Foot Complications
pre-ulcerative lesions
|
7 Participants
|
11 Participants
|
|
Foot Complications
foot ulcer
|
3 Participants
|
3 Participants
|
|
Foot Complications
subungual hematoma
|
13 Participants
|
6 Participants
|
Adverse Events
Standard Foot Care Education
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Enhanced Foot Care Education
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Foot Care Education
n=48 participants at risk
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.
|
Enhanced Foot Care Education
n=51 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
cellulitis, foot
|
0.00%
0/48 • 1 year
|
0.00%
0/51 • 1 year
|
|
Infections and infestations
lower limb amputation
|
0.00%
0/48 • 1 year
|
0.00%
0/51 • 1 year
|
Other adverse events
| Measure |
Standard Foot Care Education
n=48 participants at risk
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.
|
Enhanced Foot Care Education
n=51 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
diabetic foot ulcer
|
6.2%
3/48 • Number of events 3 • 1 year
|
5.9%
3/51 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pre-ulcerative lesion
|
14.6%
7/48 • Number of events 7 • 1 year
|
21.6%
11/51 • Number of events 11 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ingrown
|
6.2%
3/48 • Number of events 3 • 1 year
|
7.8%
4/51 • Number of events 4 • 1 year
|
|
Cardiac disorders
Hospitalization
|
16.7%
8/48 • Number of events 8 • 1 year
|
23.5%
12/51 • Number of events 12 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place