Pressure-Relieving Effect of Different Insole Top Covers in People with Diabetes at High Risk of Foot Ulceration
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Participants
2.3. Insole Top Cover Conditions
2.4. Measurements
2.5. Data Analysis
2.6. Statistical Analysis
3. Results
4. Discussion
Strengths and Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Top Cover | Material Brand Name | Thickness | Properties | Image | Shore A | Density (g/cm3) | |
---|---|---|---|---|---|---|---|
A | Top | Plastazote® 1 | 3 mm | Closed-cell polyethylene | 18 | 0.05 | |
Bottom | PPT® 2 | 3 mm | Open-cell polyurethane | 20 | 0.38 | ||
B | Top | P-cell® 3 | 3 mm | Closed-cell ethyl vinyl acetate | 20 | 0.07 | |
Bottom | PPT® 2 | 3 mm | Open-cell polyurethane | 20 | 0.38 | ||
C | Top | Nora Aero sorb W® 4 | 3 mm | Closed-cell | soft | 0.16 | |
Bottom | Nora Astro form 8® 4 | 3 mm | Open-cell | 8 | 0.21 | ||
D | PPT® 2 | 6 mm | Open-cell polyurethane | 12 | 0.35 | ||
E | PPT® 2 | 3 mm | Open-cell polyurethane | 20 | 0.38 | ||
F | Nora Lunatec Motion® 4 | 6 mm | Closed-cell | 12 | 0.13 | ||
G | Top | Poron® 5 | 3 mm | Open-cell polyurethane | 17 | 0.24 | |
Bottom | Vepur Polyurethane (PU)® 5 | 4 mm | Open-cell polyurethane | - | - | ||
H | Top | DiaPod® 6 | 4 mm | Closed-cell | 25 | 0.15 | |
Bottom | Vibram® Vipod® 6 | 2 mm | Closed-cell | 20 | 0.24 |
Participants | n = 20 |
---|---|
Characteristics | |
Age (years) | 71 ± 7 |
Sex (female/male) | 15% (3)/85% (17) |
Diabetes type (1/2) | 15% (3)/85% (17) |
Diabetes duration (years) | 20 ± 15 |
BMI (kg/m2) | 31 ± 6 |
Loss of protective sensation | 100% (20) |
Walking speed (m/s) | 1.0 ± 0.2 |
Foot ulcer history | n = 18 |
Ulcer history | 90% (18) |
| 45% (9) |
Time since healing of last ulcer (months) * | 15 ± 17 |
Foot (most recent ulcer) | |
| 39% (7) |
| 61% (11) |
Ulcer location (most recent ulcer) | |
Plantar | |
| 33% (6) |
| 28% (5) |
| 17% (3) |
| 0 |
| 5% (1) |
Dorsal | 17% (3) |
Feet | n = 40 |
ROI ** | |
| 45% (18) |
| 18% (7) |
| 28% (11) |
| 5% (2) |
| 5% (2) |
Barefoot PPP (kPa) at ROI during walking | |
| 981 (239) |
| 944 (285) |
Foot deformities *** | |
| 13% (5) |
| 8% (3) |
| 78% (31) |
| 3% (1) |
Amputations | |
| 97% (39) |
| 3% (1) |
Insole | Name (Bottom/Top) | ROI | Hallux | MTH1 | MTH23 | MTH45 | Medial Midfoot | |
---|---|---|---|---|---|---|---|---|
A | PPT/Plastazote, 6 mm | Mean | 173.5 | 153.3 | 143.2 | 149.3 | 111.0 | 107.4 |
SD | (55.9) | (68.9) | (40.6) | (32.8) | (31.8) | (37.8) | ||
B | PPT/P-cell, 6 mm | Mean | 168.3 | 149.7 | 137.7 | 148.0 | 114.9 | 107.1 |
SD | (52.0) | (67.1) | (36.1) | (31.9) | (34.8) | (35.8) | ||
C | Astro form/Aero sorb, 6 mm | Mean | 166.6 | 148.3 | 138.6 | 149.1 | 110.8 | 104.5 |
SD | (55.5) | (70.1) | (35.9) | (30.3) | (31.7) | (43.4) | ||
D | PPT, 6 mm | Mean | 171.4 | 155.7 | 142.9 | 149.0 | 112.8 | 104.4 |
SD | (57.5) | (72.0) | (36.4) | (31.0) | (31.5) | (37.6) | ||
E | PPT, 3 mm | Mean | 185.9 a | 160.3 | 153.4 c | 164.8 d | 116.2 | 112.5 g |
SD | (65.4) | (81.7) | (40.9) | (38.3) | (37.2) | (42.9) | ||
F | Lunatec, 6 mm | Mean | 168.6 | 152.3 | 142.0 | 149.2 | 111.4 | 105.6 |
SD | (66.0) | (69.1) | (39.4) | (34.7) | (31.4) | (43.1) | ||
G | Vepur/Poron, 7 mm | Mean | 175.7 b | 157.0 | 144.4 | 157.7 e | 116.6 | 105.0 |
SD | (58.0) | (72.7) | (36.5) | (38.2) | (38.8) | (41.4) | ||
H | Vipod/DiaPod, 6 mm | Mean | 174.8 | 160.5 | 148.1 | 152.6 | 119.0 f | 113.9 h |
SD | (51.5) | (69.0) | (35.0) | (27.0) | (28.6) | (36.8) | ||
F P Effect size | 6.278 <0.001 0.147 | 3.445 0.007 0.081 | 4.977 0.002 0.113 | 15.324 <0.001 0.282 | 3.426 0.024 0.081 | 7.865 <0.001 0.168 |
Insole | Name | Shoe Fit | Walking Comfort | |
---|---|---|---|---|
A | PPT/Plastazote, 6 mm | Mean | 8.1 | 8.0 |
SD | (1.2) | (1.1) | ||
B | PPT/P-cell, 6 mm | Mean | 8.1 | 8.2 |
SD | (1.4) | (1.3) | ||
C | Astro form/Aero sorb, 6 mm | Mean | 8.1 | 8.3 |
SD | (1.3) | (1.4) | ||
D | PPT, 6 mm | Mean | 8.0 | 8.3 |
SD | (1.6) | (1.2) | ||
E | PPT, 3 mm | Mean | 8.4 | 8.4 |
SD | (1.0) | (0.8) | ||
F | Lunatec, 6 mm | Mean | 8.3 | 8.3 |
SD | (1.3) | (1.0) | ||
G | Vepur/Poron, 7 mm | Mean | 7.8 | 8.0 |
SD | (1.5) | (1.5) | ||
H | Vipod/DiaPod, 6 mm | Mean | 8.3 | 8.3 |
SD | (1.4) | (1.2) |
Insole | Name | N | ROI | Hallux | MTH1 | MTH23 | MTH45 | Medial Midfoot | |
---|---|---|---|---|---|---|---|---|---|
A | PPT/Plastazote, 6 mm | 10 | Mean | 2.7 | 1.6 | −3.8 | 13.2 | −1.8 | −0.2 |
SD | 12.0 | 19.0 | 15.7 | 25.2 | 12.4 | 8.3 | |||
B | PPT/P-cell, 6 mm | 9 | Mean | 47.8 | 40.5 | −2.6 | 28.2 | 14.3 | 3.2 |
SD | 68.7 | 69.7 | 38.8 | 50.5 | 44.5 | 30.9 | |||
C | Astro form/Aero sorb, 6 mm | 9 | Mean | 12.7 | 15.3 * | −2.0 | 1.8 | 4.8 | 7.3 |
SD | 18.9 | 17.8 | 31.2 | 15.9 | 27.4 | 8.9 | |||
D | PPT, 6 mm | 7 | Mean | −2.7 | −37.6 * | −4.9 | 7.2 | 0.8 | −11.4 * |
SD | 44.5 | 33.8 | 40.9 | 38.6 | 14.3 | 29.3 | |||
E | PPT, 3 mm | 10 | Mean | −1.9 | 13.8 | −9.6 | 0.2 | −7.5 | −4.8 |
SD | 29.8 | 27.4 | 21.8 | 24.8 | 15.0 | 15.4 | |||
F | Lunatec, 6 mm | 10 | Mean | −0.7 | −10.8 | −5.1 | 9.5 | 4.6 | −5.9 |
SD | 20.1 | 25.3 | 18.3 | 19.6 | 21.2 | 15.9 | |||
G | Vepur/Poron, 7 mm | 9 | Mean | 20.4 | 19.6 | −12.6 | −30.0 * | −17.1 | −4.6 |
SD | 50.4 | 54.3 | 33.2 | 37.4 | 24.3 | 13.5 | |||
H | Vipod/DiaPod, 6 mm | 8 | Mean | 2.5 | −11.7 | −9.8 | −10.6 | −9.7 | −4.4 * |
SD | 23.1 | 22.8 | 24.7 | 19.0 | 12.8 | 23.1 |
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Bus, S.A.; Busch-Westbroek, T.E.; Pulles, J.; van Dun, T.; Szabo, G.; Lacorte, D.H.; Luckson, D.; van Netten, J.J. Pressure-Relieving Effect of Different Insole Top Covers in People with Diabetes at High Risk of Foot Ulceration. Sensors 2024, 24, 5549. https://doi.org/10.3390/s24175549
Bus SA, Busch-Westbroek TE, Pulles J, van Dun T, Szabo G, Lacorte DH, Luckson D, van Netten JJ. Pressure-Relieving Effect of Different Insole Top Covers in People with Diabetes at High Risk of Foot Ulceration. Sensors. 2024; 24(17):5549. https://doi.org/10.3390/s24175549
Chicago/Turabian StyleBus, Sicco A., Tessa E. Busch-Westbroek, Jan Pulles, Tim van Dun, Ghizella Szabo, Dario H. Lacorte, Dannick Luckson, and Jaap J. van Netten. 2024. "Pressure-Relieving Effect of Different Insole Top Covers in People with Diabetes at High Risk of Foot Ulceration" Sensors 24, no. 17: 5549. https://doi.org/10.3390/s24175549