Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Population
2.3. Treatment of Included Patients
2.3.1. Knee-High Non-Removable Offloading Devices
2.3.2. Knee-High Removable Offloading Devices
2.3.3. Ankle-High Removable Offloading Devices
2.3.4. Other
2.4. Data Collection
2.5. Outcomes
2.6. Statistical Analyses
3. Results
3.1. Baseline Characteristics
3.2. Treatment Outcome—All Patients
3.3. Treatment Outcome—Uncomplicated Ulcers
3.4. Treatment Outcomes—Complicated Ulcers
4. Discussion
4.1. Total Population
4.2. Uncomplicated Ulcers
4.3. Complicated Ulcers
4.4. Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Appendix B
Healing 20 Weeks | ||||
Univariate | p-value | Multivariate | p-value | |
odds ratio (CI-95) | odds ratio (CI-95) | |||
Age | 1.008 (0.987–1.029) | 0.451 | ||
Diabetes type | 0.827 (0.269–2.538) | 0.740 | ||
Years of diabetes | 0.999 (0.973–1.026) | 0.956 | ||
HbA1c | 0.990 (0.975–1.006) | 0.231 | ||
Hypertension | 1.037 (0.593–1.814 | 0.899 | ||
PAD | 0.227 (0.126–0.409) | <0.001 | ||
Cerebrovascular | 0.703 (0.346–1.426) | 0.329 | ||
Cardiovascular | 0.304 (0.167–0.553) | <0.001 | 0.438 (0.224–0.857) | 0.016 |
ESRD | 0.688 (0.266–1.777) | 0.440 | ||
Neuropathy | 1.191 (0.564–2.513) | 0.647 | ||
Ulcer (first/recurrent) | 0.803 (0.477–1.351) | 0.409 | ||
Number of ulcers | 0.499 (0.338–0.738) | <0.001 | 0.593 (0.381–0.922) | 0.020 |
Wound stage | 0.491 (0.378–637) | <0.001 | 0.641 (0.474–0.867) | 0.004 |
Wound grade | 0.448 (0.311–0.646) | <0.001 | 0.596 (0.392–0.905) | 0.015 |
Wound location | 0.902 (0.801–1.015) | 0.088 | ||
Healing 1 Year | ||||
Univariate | p-value | Multivariate | p-value | |
odds ratio (CI-95) | odds ratio (CI-95) | |||
Age | 0.992 (0.969–1.015) | 0.477 | ||
Diabetes type | 0.852 (0.253–2.871) | 0.797 | ||
Years of diabetes | 0.991 (0.962–1.020) | 0.542 | ||
HbA1c | 1.003 (0.985–1.021) | 0.778 | ||
Hypertension | 0.964 (0.515–1.804) | 0.908 | ||
PAD | 0.406 (0.225–0.732) | 0.003 | ||
Cerebrovascular | 0.432 (0.209–0.892) | 0.023 | 0.436 (0.203–0.936) | 0.033 |
Cardiovascular | 0.420 (0.230–0.786) | 0.005 | 0.494 (0.259–0.940) | 0.032 |
ESRD | 0.814 (0.296–2.241) | 0.691 | ||
Neuropathy | 0.854 (0.362–2.011) | 0.718 | ||
Ulcer (first/recurrent) | 1.286 (0.714–2.315) | 0.402 | ||
Number of ulcers | 0.601 (0.431–0.838) | 0.003 | 0.690 (0.483–0.985) | 0.041 |
Wound stage | 0.687 (0.534–0.885) | 0.004 | ||
Wound grade | 0.622 (0.431–0.899) | 0.011 | 0.669 (0.454–0.984) | 0.041 |
Wound location | 0.891 (0.783–1.014) | 0.080 |
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All Patients | TCC | Ankle-High Removable | Orthopaedic Shoe | Bandage Shoe | Felted Foam | p-Value | ||
---|---|---|---|---|---|---|---|---|
Patients | 235 | 3% (n = 8) | 9% (n = 22) | 32% (n = 75) | 16% (n = 38) | 39% (n = 92) | ||
Gender | Male | 66% (n = 156) | 75% (n = 6) | 86% (n = 19) | 64% (n = 48) | 63% (n = 24) | 64% (n = 60) | 0.311 |
Female | 34% (n = 79) | 25% (n = 2) | 14% (n = 3) | 36% (n = 27) | 37% (n = 14) | 36% (n = 32) | ||
Age (years), mean (SD) | 69.4 (12.4) | 57 (11.0) | 59.6 (11.9) | 71.4 (11.0) | 73.7 (11.2) | 69.3 (12.5) | <0.001 | |
Diabetes type | Type 1 | 5% (n = 13) | 13% (n = 1) | 23% (n = 5) | 4% (n = 3) | 0% (n = 0) | 4% (n = 4) | 0.003 |
Type 2 | 95% (n = 222) | 87% (n = 7) | 77% (n = 17) | 96% (n = 72) | 100% (n = 38) | 96% (n = 88) | ||
Years of diabetes | 14.9 (10.4) | 12 (5.7) | 14.7 (11.6) | 16.0 (12.2) | 11.5 (6.9) | 15.6 (9.6) | 0.287 | |
HbA1c | 61.9 (17.6) | 72.8 (20.2) | 70.8 (21.4) | 56.6 (13.4) | 60.9 (19.8) | 64.5 (17.9) | 0.006 | |
Hypertension | Yes | 70% (n = 165) | 75% (n = 6) | 68% (n = 15) | 67% (n = 50) | 68% (n = 26) | 74% (n = 68) | 0.871 |
No | 30% (n = 70) | 25% (n = 2) | 32% (n = 7) | 33% (n = 25) | 32% (n = 12) | 26% (n = 24) | ||
PAD | Yes | 34% (n = 80) | 0% (n = 0) | 23% (n = 5) | 23% (n = 17) | 42% (n = 16) | 46% (n = 42) | 0.003 |
No | 66% (n = 155) | 100% (n = 8) | 77% (n = 17) | 77% (n = 58) | 58% (n = 22) | 54% (n = 50) | ||
Cerebrovascular disease | Yes | 16% (n = 37) | 0% (n = 0) | 9% (n = 2) | 12% (n = 9) | 29% (n = 11) | 16% (n = 15) | 0.090 |
No | 84% (n = 198) | 100% (n = 8) | 91% (n = 20) | 88% (n = 66) | 71% (n = 27) | 84% (n = 77) | ||
Cardiovascular disease | Yes | 29% (n = 69) | 13% (n = 1) | 18% (n = 4) | 24% (n = 18) | 34% (n = 13) | 36% (n = 33) | 0.217 |
No | 71% (n = 166) | 87% (n = 7) | 82% (n = 18) | 76% (n = 57) | 66% (n = 25) | 64% (n = 59) | ||
ESRD | Yes | 8% (n = 19) | 0% (n = 0) | 0% (n = 0) | 8% (n = 6) | 11% (n = 4) | 10% (n = 9) | 0.509 |
No | 92% (n = 216) | 100% (n = 8) | 100% (n = 22) | 92% (n = 69) | 89% (n = 34) | 90% (n = 83) | ||
Neuropathy | Yes | 86% (n = 203) | 87% (n = 7) | 82% (n = 18) | 95% (n = 71) | 82% (n = 31) | 83% (n = 76) | 0.157 |
No | 14% (n = 32) | 13% (n = 1) | 18% (n = 4) | 5% (n = 4) | 18% (n = 7) | 17% (n = 16) |
All Patients | TCC | Ankle-High Removable | Orthopaedic Shoe | Bandage Shoe | Felted Foam | p-Value | ||
---|---|---|---|---|---|---|---|---|
Patients | 235 | 3% (n = 8) | 9% (n = 22) | 32% (n = 75) | 16% (n = 38) | 39% (n = 92) | ||
Ulcer | First ever | 59% (n = 138) | 38% (n = 3) | 54.% (n = 12) | 53% (n = 40) | 61% (n = 23) | 66% (n = 61) | 0.380 |
Recurrent | 41% (n = 97) | 62% (n = 5) | 46% (n = 10) | 47% (n = 35) | 39% (n = 15) | 34% (n = 31) | ||
Number of ulcers | 1 | 76% (n = 179) | 63% (n = 5) | 96% (n = 21) | 88% (n = 66) | 74% (n = 28) | 64% (n = 59) | 0.002 |
2 | 13% (n = 30) | 25% (n = 2) | 4% (n = 1) | 8% (n = 6) | 3% (n = 1) | 22% (n = 20) | ||
3 | 6% (n = 15) | 12% (n = 1) | 0% (n = 0) | 3% (n = 2) | 10% (n = 4) | 9% (n = 8) | ||
>3 | 5% (n = 11) | 0% (n = 0) | 0% (n = 0) | 1% (n = 1) | 13% (n = 5) | 5% (n = 5) | ||
Wound stage | A | 45% (n = 105) | 38% (n = 3) | 36% (n = 8) | 59% (n = 44) | 29% (n = 11) | 41% (n = 38) | 0.001 |
B | 21% (n = 50) | 62% (n = 5) | 41% (n = 9) | 19% (n = 14) | 29% (n = 11) | 12% (n = 11) | ||
C | 18% (n = 43) | 0% (n = 0) | 9% (n = 2) | 9% (n = 7) | 21% (n = 8) | 29% (n = 27) | ||
D | 16% (n = 37) | 0% (n = 0) | 14% (n = 3) | 13% (n = 10) | 21% (n = 8) | 17% (n = 16) | ||
Wound grade | 1 | 52% (n = 123) | 87% (n = 7) | 32% (n = 7) | 64% (n = 48) | 37% (n = 14) | 51% (n = 47) | 0.019 |
2 | 30% (n = 70) | 13% (n = 1) | 41% (n = 9) | 19% (n = 14) | 37% (n = 14) | 35% (n = 32) | ||
3 | 18% (n = 42) | 0% (n = 0) | 27% (n = 6) | 17% (n = 13) | 26% (n = 10) | 14% (n = 13) | ||
Wound location | Dig 1/Hallux | 43% (n = 100) | 25% (n = 2) | 59% (n = 13) | 47% (n = 35) | 40% (n = 15) | 38% (n = 35) | 0.281 |
Dig 2 | 8% (n = 20) | 0% (n = 0) | 14% (n = 3) | 9% (n = 7) | 5% (n = 2) | 9% (n = 8) | ||
Dig 3 | 11% (n = 25) | 12% (n = 1) | 9% (n = 2) | 11% (n = 8) | 16% (n = 6) | 9% (n = 8) | ||
Dig 4 | 4% (n = 9) | 12% (n = 1) | 0% (n = 0) | 7% (n = 5) | 0% (n = 0) | 3% (n = 3) | ||
Dig 5 | 14% (n = 33) | 25% (n = 2) | 9% (n = 2) | 15% (n = 11) | 16% (n = 6) | 13% (n = 12) | ||
Forefoot | 12% (n = 30) | 25% (n = 2) | 9% (n = 2) | 9% (n = 7) | 18% (n = 7) | 13% (n = 12) | ||
Midfoot/Hindfoot | 8% (n = 18) | 0% (n = 0) | 0% (n = 0) | 2% (n = 2) | 5% (n = 2) | 15% (n = 14) |
All Patients | TCC | Ankle-High Removable | Orthopaedic Shoe | Bandage Shoe | Felted Foam | p-Value | |||
---|---|---|---|---|---|---|---|---|---|
Patients | 235 | 3% (n = 8) | 9% (n = 22) | 32% (n = 75) | 16% (n = 38) | 39% (n = 92) | |||
Ulcer healing | 12 weeks | Yes | 33% (n = 78) | 12% (n = 1) | 18% (n = 4) | 37% (n = 28) | 29% (n = 11) | 37% (n = 34) | 0.255 |
No | 67% (n = 157) | 88% (n = 7) | 82% (n = 18) | 63% (n = 47) | 71% (n = 27) | 63% (n = 58) | |||
20 weeks | Yes | 52% (n = 121) | 25% (n = 2) | 27% (n = 6) | 59% (n = 44) | 47% (n = 18) | 55% (n = 51) | 0.013 | |
No | 48% (n = 114) | 75% (n = 6) | 73% (n = 16) | 41% (n = 31) | 53% (n = 20) | 45% (n = 41) | |||
1 year | Yes | 77% (n = 180) | 88% (n = 7) | 73% (n = 16) | 84% (n = 63) | 66% (n = 25) | 75% (n = 69) | 0.003 | |
No | 23% (n = 55) | 12% (n = 1) | 27% (n = 6) | 16% (n = 12) | 34% (n = 13) | 25% (n = 23) | |||
Time to ulcer healing (days), mean (SD) | 160.0 (134.2) | 161.5 (112.7) | 211.2 (126.0) | 133.6 (121.7) | 186.0 (145.4) | 158.4 (139.9) | 0.105 | ||
Ulcer recurrence | Yes | 25% (n = 56) | 37% (n = 3) | 32% (n = 7) | 31% (n = 23) | 18% (n = 7) | 21% (n = 19) | 0.070 | |
No | 75% (n = 171) | 63% (n = 5) | 68% (n = 15) | 69% (n = 52) | 82% (n = 31) | 79% (n = 73) | |||
Ulcer-free survival days, median (IQR) | 151.8 (134.7–169.0) | 118.3 (23.9–212.6) | 121 (72.4–170.1) | 186 (157.4–215.4) | 111 (65.7–155.9) | 151 (122.0–179.6) | 0.034 |
All Patients | TCC | Ankle-High Removable | Orthopaedic Shoe | Bandage Shoe | Felted Foam | p-Value | |||
---|---|---|---|---|---|---|---|---|---|
Patients | 103 | 3% (n = 3) | 7% (n = 7) | 42% (n = 43) | 11% (n = 11) | 37% (n = 39) | |||
Time to ulcer healing (days), mean (SD) | 122.2 (12.8) | 112.3 (79.5) | 202.5 (51.5) | 111.7 (17.2) | 188.1 (48.3) | 104.9 (20.7) | 0.287 | ||
Ulcer healing | 12 weeks | Yes | 56% (n = 58) | 67% (n = 2) | 29% (n = 2) | 54% (n = 23) | 45% (n = 5) | 67% (n = 26) | 0.321 |
No | 44% (n = 45) | 33% (n = 1) | 71% (n = 5) | 46% (n = 20) | 55% (n = 6) | 33% (n = 13) | |||
20 weeks | Yes | 71% (n = 73) | 67% (n = 2) | 43% (n = 3) | 77% (n = 33) | 55% (n = 6) | 74% (n = 29) | 0.282 | |
No | 29% (n = 30) | 33% (n = 1) | 57% (n = 4) | 23% (n = 10) | 45% (n = 5) | 26% (n = 10) | |||
1 year | Yes | 82% (n = 84) | 100% (n = 3) | 71% (n = 5) | 88% (n = 38) | 55% (n = 6) | 82% (n = 32) | 0.098 | |
No | 18% (n = 19) | 0% (n = 0) | 29% (n = 2) | 12% (n = 5) | 45% (n = 5) | 18% (n = 7) |
All Patients | TCC | Ankle-High Removable | Orthopaedic Shoe | Bandage Shoe | Felted Foam | p-Value | |||
---|---|---|---|---|---|---|---|---|---|
Patients | 132 | 4% (n = 5) | 11% (n = 15) | 24% (n = 32) | 21% (n = 27) | 40% (n = 53) | |||
Time to ulcer healing (days), mean (SD) | 207.5 (11.7) | 191.0 (39.7) | 215.3 (30.0) | 163.1 (22.1) | 227.2 (27.6) | 227.9 (18.8) | 0.218 | ||
Ulcer healing | 12 weeks | Yes | 25% (n = 33) | 0% (n = 0) | 20% (n = 3) | 38% (n = 12) | 30% (n = 8) | 19% (n = 10) | 0.206 |
No | 75% (n = 99) | 100% (n = 5) | 80% (n = 12) | 62% (n = 20) | 70% (n = 19) | 81% (n = 43) | |||
20 weeks | Yes | 35% (n = 46) | 40% (n = 2) | 27% (n = 4) | 50% (n = 16) | 30% (n = 8) | 30% (n = 16) | 0.335 | |
No | 65% (n = 86) | 60% (n = 3) | 73% (n = 11) | 50% (n = 16) | 70% (n = 19) | 70% (n = 37) | |||
1 year | Yes | 65% (n = 86) | 80% (n = 4) | 73% (n = 11) | 81% (n = 26) | 56% (n = 15) | 57% (n = 30) | 0.117 | |
No | 35% (n = 46) | 20% (n = 1) | 27% (n = 4) | 19% (n = 6) | 44% (n = 12) | 43% (n = 23) |
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Rumanes, A.; van Netten, J.J.; Hutting, K.H.; van Gemert-Pijnen, L.J.E.W.C.; van Baal, J.G. Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice. J. Clin. Med. 2025, 14, 3834. https://doi.org/10.3390/jcm14113834
Rumanes A, van Netten JJ, Hutting KH, van Gemert-Pijnen LJEWC, van Baal JG. Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice. Journal of Clinical Medicine. 2025; 14(11):3834. https://doi.org/10.3390/jcm14113834
Chicago/Turabian StyleRumanes, Afram, Jaap J. van Netten, Kor H. Hutting, Lisette J. E. W. C. van Gemert-Pijnen, and Jeff G. van Baal. 2025. "Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice" Journal of Clinical Medicine 14, no. 11: 3834. https://doi.org/10.3390/jcm14113834
APA StyleRumanes, A., van Netten, J. J., Hutting, K. H., van Gemert-Pijnen, L. J. E. W. C., & van Baal, J. G. (2025). Offloading Strategies Used for Plantar Diabetic Foot Ulcers and Their Outcomes in Real-Life Clinical Practice. Journal of Clinical Medicine, 14(11), 3834. https://doi.org/10.3390/jcm14113834