Healing Process, Pain, and Health-Related Quality of Life in Patients with Venous Leg Ulcers Treated with Fish Collagen Gel: A 12-Week Randomized Single-Center Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Interventions
2.3. Ulcer Area
2.4. Quality of Life
2.5. Ethics Statement
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Group A (n = 47) | Group B (n = 45) | |||
---|---|---|---|---|---|
Mean ± SD (Range) | Median | Mean ± SD (Range) | Median | ||
Age (Years) | 64.5 ± 12.00 (35–88) | 64.0 | 63.6 ± 11.66 (39–87) | 64.0 | |
Gender * | |||||
Female | 25 (53.2) | 23 (48.9) | |||
Male | 22 (46.8) | 24 (51.1) | |||
Duration of CVI (years) | 17.7 ± 11.9 (1–50) | 17.0 | 16.7 ± 13.7 (1–52) | 13.0 | |
Duration of VLU (months) | 72.5 ± 102.5 (4–440) | 20.0 | 40.8 ± 62.3 (2–360) | 20.0 | |
CEAP-C6 (score) | 11.6 ± 1.63 (7–15) | 12.0 | 11.6 ± 1.73 (7–16) | 11.5 | |
BMI | 31.0 ± 7.2 (19.4–58,9) | 30.7 | 30.8 ± 6.6 (20.6–58.9) | 30.5 | |
Initial wound size (cm2) | 18.3 ± 15.1 (5–50) | 11.5 | 15.4 ± 14.6 (5–50) | 8.6 | |
ABI right | 1.09 ± 0.12 (0.90–1.33) | 1.06 | 1.14 ± 0.14 (0.80–1.5) | 1.14 | |
ABI left | 1.07 ± 0.12 (0.83–1.40) | 1.06 | 1.11 ± 0.14 (0.72–1.5) | 1.10 |
Domain | Group A, n = 47 | Group B, n = 45 | |||
---|---|---|---|---|---|
Mean ± SD | Median [IQR] | Mean ± SD | Median [IQR] | p | |
HR (cm2/week)12 weeks later | 0.68 ± 0.61 | 0.56 [0.42, 0.78] | 0.51 ± 0.68 | 0.43 [0.24, 0.68] | 0.598 |
13 (27.7%) * | 11 (24.4%) * | 0.675 | |||
HR (cm2/week) 24 weeks later | 0.42 ± 0.44 | 0.33 [0.22, 0.49] | 0.33 ± 0.31 | 0.24 [0.21, 0.41] | 0.219 |
25 (53.2%) * | 18 (40.0%) * | 0.223 | |||
I. SKINDEX-29, Initial Assessment | |||||
PS | 17.79 ± 5.13 | 17.00 [14.00, 21.00] | 15.69 ± 5.21 | 16.00 [12.25, 21.75] | 0.420 |
PF | 23.96 ± 8.77 | 21.00 [18.00, 29.00] | 21.73 ± 7.04 | 20.00 [16.00, 28.00] | 0.497 |
ES | 21.79 ± 7.35 | 21.00 [16.75, 25.00] | 19.88 ± 5.60 | 20.00 [17.00, 25.00] | 0.691 |
TS | 63.53 ± 18.92 | 60.00 [49.50, 72.25] | 57.31 ± 15.61 | 57.00 [47.00, 74.00] | 0.479 |
II. SKINDEX-29, 12 Weeks Later | |||||
PS | 14.49 ± 4.49 | 14.00 [11.00, 17.00] | 15.16 ± 5.09 | 16.00 [10.00, 19.00] | 0.578 |
PF | 19.32 ± 7.32 | 15.00 [12.75, 21.25] | 17.51 ± 5.85 | 16.00 [12.00, 21.00] | 0.968 |
ES | 18.98 ± 7.08 | 14.00 [11.00, 18.25] | 16.18 ± 4.83 | 15.00 [11.00, 19.00] | 0.651 |
TS | 52.79 ± 17.34 | 47.00 [39.00, 56.25] | 52.87 ± 14.93 | 50.00 [38.00, 64.00] | 0.516 |
III. SKINDEX-29, 24 Weeks Later | |||||
PS | 13.47 ± 5.12 | 11.50 [9.00, 15.25] | 13.29 ± 4.57 | 13.00 [9.00, 15.00] | 0.951 |
PF | 18.30 ± 8.05 | 14.00 [11.00, 18.50] | 16.16 ± 4.98 | 14.00 [11.00, 18.00] | 0.951 |
ES | 18.23 ± 7.06 | 12.50 [10.00, 20.00] | 15.00 ± 4.73 | 14.00 [11.00, 19.00] | 0.811 |
TS | 50.00 ± 18.53 | 41.50 [35.00, 54.75] | 48.40 ± 13.91 | 43.00 [35.00, 55.00] | 0.673 |
CIVIQ, Initial Assessment | |||||
Pain | 11.13 ± 3.30 | 11.00 [8.75, 13.25] | 10.80 ± 3.47 | 11.00 [8.00, 13.00] | 0.533 |
PhD | 11.28 ± 3.66 | 12.00 [8.00, 14.25] | 11.24 ± 3.61 | 12.00 [8.00, 14.00] | 0.811 |
PsD | 20.13 ± 6.83 | 18.50 [15.00, 23.50] | 18.84 ± 6.46 | 8.00 [6.00, 9.00] | 0.437 |
ScD | 7.89 ± 2.80 | 7.50 [6.00, 10.00] | 7.87 ± 2.74 | 8.00 [6.00, 9.00] | 0.749 |
TS | 50.43 ± 13.40 | 50.00 [38.50, 60.50] | 48.76 ± 13.79 | 50.00 [38.50, 60.00] | 0.444 |
GIS | 38.03 ± 16.75 | 37.50 [23.12, 50.62] | 35.95 ± 17.01 | 38.75 [22.50, 50.000] | |
CIVIQ, 12 Weeks Later | |||||
Pain | 8.74 ± 3.54 | 8.00 [6.00, 11.00] | 8.78 ± 3.32 | 7.00 [6.00, 11.00] | 0.667 |
PhD | 10.28 ± 3.28 | 10.50 [6.75, 13.00] | 10.47 ± 3.92 | 11.00 [6.00, 13.00] | 0.854 |
PsD | 16.94 ± 6.02 | 15.00 [11.75, 21.25] | 17.67 ± 5.40 | 17.00 [13.00, 21.00] | 0.548 |
ScD | 7.30 ± 2.67 | 7.00 [5.00, 9.00] | 7.02 ± 2.46 | 6.00 [5.00, 8.00] | 0.358 |
TS | 43.26 ± 13.52 | 41.00 [31.50, 51.50] | 43.93 ± 12.11 | 42.00 [34.00, 53.00] | 0.860 |
GIS | 29.06 ± 16.90 | 26.25 [16.87, 40.00] | 29.91 ± 14.96 | 28.75 [20.00, 42.50] | |
CIVIQ, 24 Weeks Later | |||||
Pain | 8.00 ± 3.21 | 7.00 [5.00, 9.00] | 7.87 ± 3.69 | 7.00 [5.00, 9.00] | 0.816 |
PhD | 10.15 ± 3.62 | 10.00 [6.00, 12.25] | 10.24 ± 4.87 | 10.00 [6.00, 12.00] | 0.845 |
PsD | 16.44 ± 6.31 | 13.00 [11.00, 20.00] | 16.89 ± 3.18 | 15.00 [11.00, 20.00] | 0.685 |
ScD | 7.13 ± 2.57 | 7.00 [5.00, 9.00] | 6.96 ± 2.59 | 6.00 [4.00, 8.00] | 0.279 |
TS | 41.04 ± 13.54 | 37.00 [28.75, 50.25] | 41.96 ± 11.97 | 39.00 [30.00, 49.00] | 0.877 |
GIS | 26.30 ± 17.03 | 21.25 [12.50, 38.12] | 27.45 ± 18.13 | 25.00 [15.00, 37.50] |
Item | Group A | Group B | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean ± SD | Mean ± SD | Mean ± SD | I–II | I–III | Mean ± SD | Mean ± SD | Mean ± SD | I–II | I–III | ||
1 | My skin hurts ** | 2.47 ± 1.40 | 2.11 ± 1.20 | 1.70 ± 1.00 | 0.36 | 0.77 | 2.40 ± 1.34 | 2.24 ± 1.25 | 1.89 ± 1.15 | 0.16 | 0.51 |
2 | My skin condition affects how well I sleep ** | 2.43 ± 1.30 | 1.85 ± 1.08 | 1.68 ± 1.07 | 0.57 | 0.74 | 2.47 ± 1.39 | 2.13 ± 1.20 | 1.87 ± 1.04 | 0.33 | 0.60 |
3 | I worry that my skin condition may be serious ** | 3.26 ± 1.19 | 2.83 ± 1.32 | 2.74 ± 1.28. | 0.43 | 0.51 | 3.00 ± 1.07 | 2.89 ± 1.07 | 2.82 ± 1.03 | 0.11 | 0.18 |
4 | My skin condition makes it hard to work or do hobbies * | 2.47 ± 1.27 | 2.00 ± 1.12 | 1.74 ± 0.99 | 0.47 | 0.72 | 2.51 ± 1.25 | 2.18 ± 1.07 | 2.09 ± 1.04 | 0.33 | 0.42 |
5 | My skin condition affects my social life * | 2.22 ± 1.23 | 1.62 ± 0.95 | 1.55 ± 0.93 | 0.60 | 0.66 | 1.82 ± 1.03 | 1.51 ± 0.76 | 1.31 ± 0.60 | 0.31 | 0.51 |
6 | My skin condition makes me feel depressed * | 2.51 ± 1.16 | 2.09 ± 1.10 | 2.02 ± 1.13 | 0.43 | 0.49 | 2.44 ± 1.22 | 1.80 ± 0.92 | 1.84 ± 0.85 | 0.64 | 0.60 |
7 | My skin condition burns or strings ** | 2.83 ± 1.22 | 2.43 ± 1.17 | 2.02 ± 1.15 | 0.40 | 0.81 | 2.56 ± 1.20 | 2.27 ± 1.23 | 2.09 ± 1.02 | 0.29 | 0.47 |
8 | I tend to stay at home because of my skin condition | 2.11 ± 1.17 | 1.55 ± 0.97 | 1.53 ± 0.95 | 0.55 | 0.57 | 2.09 ± 1.20 | 1.56 ± 0.92 | 1.42 ± 0.81 | 0.53 | 0.62 |
9 | I worry about getting scars from my skin condition ** | 1.68 ± 1.04 | 1.60 ± 1.10 | 1.40 ± 0.74 | 0.08 | 0.28 | 1.47 ± 0.76 | 1.76 ± 1.03 | 1,58 ± 0.87 | -0.29 | -0.11 |
10 | My skin itches | 3.00 ± 1.25 | 2.72 ± 1.23 | 2.53 ± 1.27 | 0.28 | 0.47 | 3.04 ± 1.30 | 2.71 ± 1.10 | 2.50 ± 1.11 | 0.33 | 0.54 |
11 | My skin condition affects how close I can be with those I love | 1.68 ± 0.91 | 1.51 ± 0.86 | 1.34 ± 0.73 | 0.17 | 0.34 | 1,58 ± 1.06 | 1.36 ± 0.68 | 1.33 ± 0.67 | 0.22 | 0.25 |
12 | I am ashamed of my skin condition * | 2.02 ± 1.15 | 1.98 ± 1.34 | 1.70 ± 1.02 | 0.04 | 0.32 | 1.87 ± 1.08 | 1.93 ± 1.01 | 1.78 ± 0.97 | -0.07 | 0.09 |
13 | I worry that my skin condition may get worse | 2.77 ± 1.24 | 2.68 ± 1.14 | 2.72 ± 1.14 | 0.09 | 0.04 | 2.69 ± 0.95 | 2.78 ± 1.22 | 2.67 ± 1.22 | -0.09 | 0.02 |
14 | I tend to do things by myself because of my skin condition ** | 2.17 ± 1.19 | 1.89 ± 1.20 | 1.74 ± 1.15 | 0.28 | 0.43 | 2.27 ± 1.25 | 1.67 ± 1.13 | 1.47 ± 0.97 | 0.60 | 0.80 |
15 | I am angry about my skin condition | 1.81 ± 1.06 | 1.51 ± 0.88 | 1.49 ± 0.78 | 0.30 | 0.32 | 1.87 ± 1.12 | 1.47 ± 0.84 | 1.42 ± 0.81 | 0.40 | 0.44 |
16 | Water bothers my skin condition (bathing, washing) ** | 1.85 ± 1.18 | 1.30 ± 0.69 | 1.40 ± 0.80 | 0.55 | 0.45 | 1.49 ± 0.89 | 1.42 ± 0.94 | 1.29 ± 0.73 | 0.07 | 0.20 |
17 | My skin condition makes showing affection difficult | 1.74 ± 1.11 | 1.47 ± 0.95 | 1.40 ± 0.77 | 0.28 | 0.34 | 1.53 ± 0.99 | 1.31 ± 0.76 | 1.24 ± 0.61 | 0.22 | 0.29 |
18 | My skin is irritated | 2.62 ± 1.23 | 2.06 ± 0.96 | 2.15 ± 1.06 | 0.55 | 0.47 | 2.73 ± 1.23 | 2.29 ± 1.18 | 2.09 ± 1.18 | 0.44 | 0.64 |
19 | My skin condition affects my interactions with others | 1.51 ± 0.88 | 1.23 ± 0.56 | 1.36 ± 0.76 | 0.28 | 0.15 | 1.51 ± 1.01 | 1.36 ± 0.74 | 1.33 ± 0.71 | 0.16 | 0.18 |
20 | I am embarrassed by my skin condition * | 2.13 ± 1.10 | 1.60 ± 0.92 | 1.60 ± 0.85 | 0.53 | 0.53 | 2.16 ± 1.13 | 1.84 ± 1.00 | 1.71 ± 0.92 | 0.31 | 0.44 |
21 | My skin condition is a problem for the people I love | 1.87 ± 1.15 | 1.53 ± 0.95 | 1.43 ± 0.90 | 0.34 | 0.45 | 1.93 ± 1.23 | 1.31 ± 0.68 | 1.36 ± 0.74 | 0.62 | 0.58 |
22 | I am frustrated by my skin condition | 1.81 ± 1.04 | 1.74 ± 0.99 | 1.68 ± 0.96 | 0.06 | 0.13 | 1.96 ± 1.11 | 1.62 ± 0.86 | 1.53 ± 0.84 | 0.33 | 0.42 |
23 | My skin is sensitive ** | 2.98 ± 1.11 | 2.38 ± 0.99 | 2.28 ± 1.02 | 0.60 | 0.70 | 2.91 ± 1.29 | 2.80 ± 1.16 | 2.47 ± 1.08 | 0.11 | 0.44 |
24 | My skin condition affects my desire to be with people | 1.68 ± 1.02 | 1.45 ± 0.75 | 1.34 ± 0.73 | 0.23 | 0.34 | 1.60 ± 1.10 | 1.29 ± 0.59 | 1.27 ± 0.62 | 0.31 | 0.33 |
25 | I am humiliated by my skin condition | 1.66 ± 0.96 | 1.36 ± 0.76 | 1.34 ± 0.64 | 0.30 | 0.32 | 1.64 ± 1.05 | 1.36 ± 0.74 | 1.29 ± 0.69 | 0.29 | 0.36 |
26 | My skin condition bleeds | 2.04 ± 1.04 | 1.49 ± 0.80 | 1.38 ± 0.80 | 0.55 | 0.66 | 1.82 ± 1.07 | 1.42 ± 0.72 | 1.38 ± 0.68 | 0.40 | 0.44 |
27 | I am annoyed by my skin condition | 2.15 ± 1.23 | 1.60 ± 0.92 | 1.53 ± 0.86 | 0.55 | 0.62 | 1.96 ± 1.04 | 1.51 ± 0.84 | 1.49 ± 0.84 | 0.44 | 0.47 |
28 | My skin condition interferes with my sex life | 1.47 ± 1.00 | 1.26 ± 0.87 | 1.11 ± 0.60 | 0.21 | 0.36 | 1.62 ± 1.17 | 1.24 ± 0.68 | 1.24 ± 0.83 | 0.38 | 0.38 |
29 | My skin condition makes me tired | 2.62 ± 1.13 | 1.96 ± 1.08 | 2.06 ± 1.15 | 0.66 | 0.55 | 2.40 ± 1.12 | 1.84 ± 1.07 | 1.80 ± 1.06 | 0.56 | 0.60 |
Statement | Group A | Group B | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean ± SD | Mean ± SD | Mean ± SD | I–II | I–III | Mean ± SD | Mean ± SD | Mean ± SD | I–II | I–III | ||
1 | Have you had any pain in your ankles or legs, and how severe has this pain been? * | 3.17 ± 1.13 | 2.36 ± 1.26 | 1.72 ± 0.97 | 0.81 | 1.45 | 2.93 ± 1.21 | 2.20 ± 1.08 | 1.91 ± 1.14 | 0.73 | 1.02 |
2 | How much trouble have you experienced at work or during your usual daily activities because of your leg problems? * | 2.77 ± 0.96 | 2.17 ± 1.03 | 2.09 ± 0.97 | 0.60 | 0.68 | 2.49 ± 1.10 | 2.24 ± 0.98 | 1.93 ± 0.96 | 0.24 | 0.56 |
3 | How much trouble have you experienced at work or during your usual daily activities because of your leg problems? | 2.51 ± 1.28 | 1.79 ± 1.14 | 1.53 ± 1.02 | 0.72 | 0.98 | 2.71 ± 1.22 | 1.93 ± 1.05 | 1.62 ± 1.01 | 0.78 | 1.09 |
4 | How much trouble have you had remaining standing for a long time? * | 2.68 ± 1.12 | 1.43 ± 1.21 | 2.26 ± 1.19 | 0.26 | 0.43 | 2.67 ± 1.26 | 2.40 ± 1.10 | 2.40 ± 1.18 | 0.27 | 0.27 |
5 | Climbing several flights of stairs? | 2.74 ± 1.15 | 2.28 ± 1.14 | 2.45 ± 1.08 | 0.47 | 0.30 | 2.51 ± 1.12 | 2.36 ± 1.15 | 2.27 ± 1.05 | 0.16 | 0.24 |
6 | Crouching, kneeling down | 3.38 ± 1.17 | 3.23 ± 1.24 | 2.94 ± 1.19 | 0.15 | 0.45 | 3.47 ± 1.22 | 3.29 ± 1.34 | 3.27 ± 1.30 | 0.18 | 0.20 |
7 | Walking at a brisk pace | 2.98 ± 1.19 | 2.94 ± 1.24 | 2.79 ± 1.20 | 0.04 | 0.19 | 3.16 ± 1.22 | 2.93 ± 1.27 | 2.87 ± 1.20 | 0.22 | 0.29 |
8 | Travelling by car, bus, plane | 2.15 ± 1.12 | 1.85 ± 1.00 | 1.85 ± 1.02 | 0.30 | 0.30 | 2.22 ± 1.04 | 1.73 ± 1.03 | 1.76 ± 0.93 | 0.49 | 0.47 |
9 | Performing household tasks (e.g., standing and moving around in the kitchen, carrying a child in your arms, ironing, cleaning the floor or dusting the furniture) * | 2.17 ± 1.05 | 1.83 ± 0.96 | 1.74 ± 0.90 | 0.34 | 0.43 | 2.11 ± 0.98 | 1.89 ± 0.91 | 1.84 ± 0.95 | 0.22 | 0.27 |
10 | Going out for the evening, going to a wedding, a party, a cocktail party | 2.32 ± 1.16 | 1.96 ± 1.04 | 1.94 ± 1.01 | 0.36 | 0.38 | 2.21 ± 1.14 | 1.73 ± 0.99 | 1.71 ± 0.99 | 0.47 | 0.49 |
11 | Playing a sport, exerting yourself physically | 3.43 ± 1.17 | 3.49 ± 1.28 | 3.42 ± 1.36 | −0.06 | 0.00 | 3.44 ± 1.34 | 3.56 ± 1.22 | 3.49 ± 1.29 | −0.11 | −0.04 |
12 | I have felt nervous/tense * | 2.15 ± 1.06 | 1.85 ± 1.00 | 1.55 ± 0.95 | 0.30 | 0.60 | 2.04 ± 1.11 | 1.77 ± 1.10 | 1.08 ± 1.04 | 0.27 | 0.24 |
13 | I have become tired quickly ** | 2.66 ± 1.09 | 2.19 ± 1.06 | 1.83 ± 1.07 | 0.47 | 0.83 | 2.58 ± 1.01 | 2.44 ± 1.12 | 2.20 ± 1.01 | 0.13 | 0.38 |
14 | I have felt I am a burden | 1.62 ± 0.99 | 1.45 ± 0.85 | 1.30 ± 0.75 | 0.17 | 0.32 | 1.58 ± 0.87 | 1.36 ± 0.71 | 1.24 ± 0.57 | 0.22 | 0.33 |
15 | I have had to be cautious all the time | 2.79 ± 1.12 | 2.36 ± 1.07 | 2.43 ± 1.04 | 0.43 | 0.36 | 2.87 ± 1.25 | 2.73 ± 1.25 | 2.93 ± 1.05 | 0.13 | −0.07 |
16 | I have felt embarrassed about showing my legs ** | 2.79 ± 1.37 | 2.34 ± 1.27 | 2.17 ± 1.19 | 0.45 | 0.62 | 2.16 ± 1.19 | 2.24 ± 1.30 | 2.13 ± 1.10 | −0.09 | 0.02 |
17 | I have become irritated easily ** | 2.68 ± 1.32 | 2.17 ± 1.29 | 1.98 ± 1.21 | 0.51 | 0.70 | 2.33 ± 1.13 | 2.31 ± 1.12 | 2.24 ± 1.09 | 0.02 | 0.09 |
18 | I have felt as if I am handicapped * | 1.98 ± 1.24 | 1.64 ± 1.05 | 1.62 ± 0.99 | 0.34 | 0.36 | 1.82 ± 1.21 | 1.71 ± 1.12 | 1.60 ± 0.91 | 0.11 | 0.22 |
19 | I have found it hard to get going in the morning | 1.66 ± 1.20 | 1.40 ± 0.77 | 1.70 ± 1.00 | 0.26 | 0.04 | 1.69 ± 1.06 | 1.67 ± 1.00 | 1.44 ± 0.84 | 0.02 | 0.24 |
20 | I have not felt like going out | 1.81 ± 1.04 | 1.57 ± 0.96 | 1.64 ± 1.03 | 0.24 | 0.17 | 1.78 ± 1.06 | 1.47 ± 0.81 | 1.29 ± 0.63 | 0.31 | 0.49 |
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Mościcka, P.; Cwajda-Białasik, J.; Szewczyk, M.T.; Jawień, A. Healing Process, Pain, and Health-Related Quality of Life in Patients with Venous Leg Ulcers Treated with Fish Collagen Gel: A 12-Week Randomized Single-Center Study. Int. J. Environ. Res. Public Health 2022, 19, 7108. https://doi.org/10.3390/ijerph19127108
Mościcka P, Cwajda-Białasik J, Szewczyk MT, Jawień A. Healing Process, Pain, and Health-Related Quality of Life in Patients with Venous Leg Ulcers Treated with Fish Collagen Gel: A 12-Week Randomized Single-Center Study. International Journal of Environmental Research and Public Health. 2022; 19(12):7108. https://doi.org/10.3390/ijerph19127108
Chicago/Turabian StyleMościcka, Paulina, Justyna Cwajda-Białasik, Maria Teresa Szewczyk, and Arkadiusz Jawień. 2022. "Healing Process, Pain, and Health-Related Quality of Life in Patients with Venous Leg Ulcers Treated with Fish Collagen Gel: A 12-Week Randomized Single-Center Study" International Journal of Environmental Research and Public Health 19, no. 12: 7108. https://doi.org/10.3390/ijerph19127108