Determining the Best Noninvasive Test for Peripheral Arterial Disease Diagnosis to Predict Diabetic Foot Ulcer Healing in Patients Following Endovascular Revascularization
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Participants
2.3. Procedures
2.4. Evaluation of Noninvasive Tests at Visit 0 and Visit 1
2.5. Endovascular Revascularization
2.6. Sample Size
2.7. Statistical Analysis
2.8. Outcome Measures
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | Not Healed (n = 8) | Healed (n = 20) | p-Value |
---|---|---|---|
Male, n (%) | 7 (87.5) | 17 (85) | 0.864 |
Female, n (%) | 1 (12.5) | 3 (15) | |
Age (years), mean ± SD | 76.75 ± 13.23 | 75.15 ± 9.03 | 0.047 * |
Type 1 DM, n (%) | 0 (0) | 1 (5) | 0.520 |
Type 2 DM, n (%) | 8 (100) | 19 (95) | |
DM duration (years) | 19.25 ± 9.92 | 24.15 ± 10.95 | 0.670 |
HbA1c (%) | 7.0 (6.5–7.9) | 7.2 (6.6–8.8) | 0.494 |
BMI, mean ± SD | 22.51 ± 1.29 | 24.81 ± 2.98 | 0.057 |
Hypertension, n (%) | 7 (87.5) | 20 (100) | 0.107 |
Hypercholesterolemia, n (%) | 8 (100) | 15 (75) | 0.119 |
Neuropathy, n (%) | 6 (75) | 11 (55) | 0.328 |
Retinopathy, n (%) | 3 37.5) | 4 (20) | 0.334 |
Nephropathy, n (%) | 2 (25) | 2 (10) | 0.306 |
Cardiopathy, n (%) | 7 (87.5) | 11 (55) | 0.105 |
Previous amputation, n (%) | 2 (25) | 5 (25) | 1.000 |
Texas grade and stage (%) | |||
1C | 4 (50) | 10 (50) | 1.000 |
2C | 1 (12.5) | 0 (0) | 0.107 |
3C | 0 (0) | 1 (5) | 0.520 |
1D | 1 (12.5) | 1 (5) | 0.486 |
2D | 2 (25) | 1 (5) | 0.122 |
3D | 0 (0) | 7 (33.3) | 0.053 |
Presence of distal pulses, n (%) | 0 (0) | 0 (0) | NA |
AP | 52.5 (21.25; 99.75) | 42 (13.0; 72.25) | 0.636 |
TP | 25.0 (17.0; 50.0) | 26.0 (17.5; 40.5) | 0.940 |
ABPI | 0.42 (0.16; 0.70) | 0.32 (0.09; 0.52) | 0.381 |
TBPI | 0.19 (0.11; 0.35) | 0.19 (0.11; 0.30) | 0.862 |
TcPO2 (mmHg) | 23.25 ± 20.07 | 35.40 ± 22.3 | 0.193 |
SPP (mmHg) | 36.5 (20.25; 73.5) | 38.5 (16.75; 54.0) | 0.820 |
RAC, n (%) | 4 (57.1) | 17 (81) | 0.204 |
Antiplatelet treatments, n (%) | 5 (71.4) | 18 (85.7) | 0.393 |
Statins, n (%) | 7 (100) | 17 (81) | 0.212 |
Anticoagulant, n (%) | 3 (42.9) | 5 (23.8) | 0.334 |
Antihypertensives, n (%) | 6 (85.7) | 21 (100) | 0.078 |
Oral antidiabetics, n (%) | 5 (71.4) | 16 (76.2) | 0.801 |
Insulin, n (%) | 3 (42.9) | 9 (42.9) | 1.000 |
AP | TP | ABPI | TBPI | TcPO2 | SPP | |
---|---|---|---|---|---|---|
Visit 0 (Before revascularization) | 48.5 (17.0; 72.75) | 26.0 (17.5; 40.5) | 0.32 (0.13; 0.56) | 0.19 (0.11; 0.30) | 33.5 (11.0; 49.0) | 35.0 (29.0; 69.0) |
Visit 1 (4 weeks after revascularization) | 65.5 (46.0; 63.75) | 49.0 (34.2; 63.75) | 0.51 (0.38; 0.67) | 0.34 (0.25; 0.43) | 39.0 (19; 59.0) | 38.5 (20.25; 59.5) |
p-value | p < 0.001 * | p < 0.001 * | p = 0.002 * | p < 0.001 * | p < 0.001 * | p = 0.013 * |
AP | TP | ABPI | TBPI | TcPO2 | SPP | |
---|---|---|---|---|---|---|
Healed n = 20 | 85.20 ± 37.5 | 55.0 (17.5; 40.5) | 0.57 ± 0.22 | 0.34 (0.27; 0.45) | 49.05 ± 18.5 | 55.76 ± 34.11 |
Not healed n = 8 | 46.75 ± 28.09 | 33.0 (27.25; 43.25) | 0.39 ± 0.26 | 0.29 (0.18; 0.35) | 12.12 ± 12.33 | 30.66 ± 21.15 |
p-value | p = 0.015 * | p = 0.008 * | p = 0.077 | p = 0.079 | p < 0.001 * | p = 0.108 |
Combination of Noninvasive Tests | Cut-Off Point | Sensitivity | Specificity | PPV | NPV | PLR | NLR |
---|---|---|---|---|---|---|---|
AP and TP | 68–46 mmHg | 0.85 | 0.62 | 0.85 | 0.62 | 2.27 | 0.24 |
ABPI and TBPI | 0.70–0.37 | 0.70 | 0.75 | 0.87 | 0.50 | 2.8 | 0.40 |
TcPO2 and SPP | 24–37 mm Hg | 0.90 | 0.62 | 0.96 | 0.29 | 2.4 | 0.16 |
TP and TcPO2 | 46–24 mmHg | 0.95 | 0.62 | 0.86 | 0.83 | 2.53 | 0.08 |
AP | TP | ABPI | TBPI | TcPO2 | SPP | |
---|---|---|---|---|---|---|
Major amputation n = 4 | 30.75 ± 15.33 | 27.5 (15.75; 41.5) | 0.25 ± 0.16 | 0.23 (0.10; 0.32) | 6.00 ± 5.48 | 40.66 ± 24.95 |
Not Major amputation n = 24 | 81.46 ± 36.81 | 52.0 (35.0; 69.5) | 0.56 ± 0.22 | 0.38 (0.27; 0.45) | 43.69 ± 21.27 | 50.50 ± 34.14 |
p-value | p = 0.013 * | p = 0.012 * | p = 0.013 * | p = 0.059 | p < 0.001 * | p = 0.639 |
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Álvaro-Afonso, F.J.; García-Álvarez, Y.; García-Morales, E.A.; Flores-Escobar, S.; De Benito-Fernández, L.; Alfayate-García, J.; Sánchez-Ríos, J.P.; Puras-Mallagray, E.; Malo-Benages, E.J.; Ramírez-Ortega, M.; et al. Determining the Best Noninvasive Test for Peripheral Arterial Disease Diagnosis to Predict Diabetic Foot Ulcer Healing in Patients Following Endovascular Revascularization. Healthcare 2024, 12, 1664. https://doi.org/10.3390/healthcare12161664
Álvaro-Afonso FJ, García-Álvarez Y, García-Morales EA, Flores-Escobar S, De Benito-Fernández L, Alfayate-García J, Sánchez-Ríos JP, Puras-Mallagray E, Malo-Benages EJ, Ramírez-Ortega M, et al. Determining the Best Noninvasive Test for Peripheral Arterial Disease Diagnosis to Predict Diabetic Foot Ulcer Healing in Patients Following Endovascular Revascularization. Healthcare. 2024; 12(16):1664. https://doi.org/10.3390/healthcare12161664
Chicago/Turabian StyleÁlvaro-Afonso, Francisco Javier, Yolanda García-Álvarez, Esther Alicia García-Morales, Sebastián Flores-Escobar, Luis De Benito-Fernández, Jesús Alfayate-García, Juan Pedro Sánchez-Ríos, Enrique Puras-Mallagray, Esteban Javier Malo-Benages, Marta Ramírez-Ortega, and et al. 2024. "Determining the Best Noninvasive Test for Peripheral Arterial Disease Diagnosis to Predict Diabetic Foot Ulcer Healing in Patients Following Endovascular Revascularization" Healthcare 12, no. 16: 1664. https://doi.org/10.3390/healthcare12161664