Background
Method
Data source, recruitment and sample
Inclusion criteria | |
• ≥ 18 years old | |
• Having a painful IPK for at least 3 months | |
Exclusion criteria | |
• Ongoing pregnancy or breastfeeding | |
• Severe cardiovascular or neurological disease | |
• Immunosuppressed status | |
• Presence of a plantar ulcer | |
• Allergy to lidocaine | |
• History of keloid or hypertrophic scar | |
• Simultaneous painful plantar syndrome unrelated to the presence of an IPK |
Randomization and blinding
Intervention description
Data collection and outcomes measures
Statistical analysis
Results
Feasibility
Safety
Group comparisons
Number of patients (Total = 40) | Group 1 n = 10 | Group 2 n = 10 | Group 3 n = 10 | Group 4 n = 10 | Pa value |
---|---|---|---|---|---|
Age in years, Mean (SD) | 59.7 (18.8) | 60.1 (14.8) | 61.6 (14.4) | 50.3 (17.7) | 0.4 |
Sex ratio, M:W | 6:4 | 3:7 | 4:6 | 4:6 | – |
Time since IPK apparition in months, Mean (SD) | 213.0 (228.3) | 192.6 (140.9) | 132.0 (74.7) | 62.8 (69.2) | 0.1 |
Time before first consultation in weeks, Mean (SD) | 439.4 (602.4) | 153.4 (198.6) | 242.0 (503.5) | 119.2 (201.2) | 0.3 |
Time spent standing hours/day, Mean (SD) | 6.5 (2.9) | 6.0 (2.3) | 7.9 (3.2) | 6.9 (3.2) | 0.5 |
Debridement frequency before study in days, Mean (SD) | 100.9 (102.2) | 142.8 (134.4) | 98.9 (29.0) | 91.3 (38.3) | 0.6 |
Smoking (n) | 6 | 2 | 2 | 4 | 0.2 |
Plantar orthoses worn daily (n) | 5 | 3 | 4 | 2 | 0.5 |
Macerated IPK at first visit (n) | 6 | 3 | 3 | 3 | 0.4 |
Presence of foot deformity (n) | 3 | 6 | 4 | 2 | 0.3 |
IPK location ratio, Met:H:S | 10:0:0 | 10:0:0 | 7:2:1 | 7:0:2 | – |
Clinical outcomes
Group 1 | Group 2 | Group 3 | Group 4 | ||||||
---|---|---|---|---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||||
n = 10 at baseline | n = 10 at baseline | n = 10 at baseline | n = 10 at baseline | ||||||
VAS | Baseline | 4.8 | (2.1) | 3.7 | (2.0) | 4.2 | (2.9) | 3.5 | (3.0) |
(0–10) | T2 | 1.9 | (2.6) | 1.7 | (2.3) | 1.0 | (1.6) | 1.7 | (2.3) |
T3 | 2.6 | (3.0) | 1.2 | (2.1) | 0.7 | (1.3) | 1.2 | (2.3) | |
T4 | 2.8 | (3.0) | 0.2 | (0.3) | 0.6 | (1.4) | 1.2 | (2.3) | |
T6 | 4.0 | (3.6) | 3.1 | (3.0) | 2.2 | (3.1) | 1.2 | (2.3) | |
T12 | 5.3 | (3.7) | 1.8 | (2.7) | 2.2 | (2.4) | 2.7 | (2.8) | |
FFI-R | Baseline | 68.8 | (17.1) | 57.8 | (29.4) | 69.6 | (34.7) | 53.4 | (29.6) |
(/270) | T2 | 45.1 | (20.9) | 45.1 | (26.2) | 37.3 | (25.8) | 37.1 | (22.9) |
T3 | 51.1 | (37.1) | 30.1 | (11.7) | 32.4 | (22.6) | 32.6 | (23.4) | |
T4 | 41.2 | (23.7) | 28.5 | (13.7) | 31.1 | (24.8) | 32.5 | (23.4) | |
T6 | 54.1 | (41.9) | 34.4 | (21.9) | 46.3 | (42.4) | 31.9 | (23.6) | |
T12 | 63.5 | (48.5) | 37.7 | (22.9) | 33.3 | (14.0) | 34.4 | (22.7) | |
IPK’s Width | Baseline | 3.4 | (1.6) | 3.3 | (2.7) | 3.1 | (1.6) | 2.0 | (1.5) |
(mm) | T2 | 2.8 | (0.9) | 2.1 | (1.3) | 2.8 | (2.6) | 2.1 | (0.9) |
T3 | 2.1 | (0.9) | 1.7 | (1.5) | 2.5 | (3.4) | 1.4 | (1.4) | |
T4 | 2.1 | (1.4) | 1.9 | (1.6) | 0.9 | (1.1) | 1.4 | (1.4) | |
IPK’s Length | Baseline | 2.7 | (1.0) | 2.9 | (2.7) | 3.4 | (2.2) | 2.5 | (1.5) |
(mm) | T2 | 2.7 | (1.0) | 2.1 | (1.6) | 2.8 | (2.6) | 2.1 | (1.2) |
T3 | 2.5 | (1.1) | 1.9 | (1.4) | 3.0 | (4.1) | 1.6 | (1.6) | |
T4 | 2.3 | (1.5) | 1.8 | (1.4) | 1.1 | (1.5) | 1.6 | (1.6) | |
IPK’s Depth | Baseline | 1.7 | (0.7) | 1.7 | (0.8) | 1.7 | (0.6) | 1.5 | (0.9) |
(mm) | T2 | 1.4 | (0.5) | 1.1 | (0.9) | 0.8 | (0.4) | 1.0 | (0.7) |
T3 | 0.9 | (0.1) | 0.8 | (0.7) | 0.3 | (0.3) | 0.7 | (0.8) | |
T4 | 1.0 | (0.7) | 0.8 | (0.6) | 0.3 | (0.4) | 0.7 | (0.8) |