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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3876_Библиотеки_им_академика_М_И_Перельмана
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21.1.1.6 Negative Pressure Therapy
• We suggest against routine primary use of negative pressure wound therapy for
venous leg ulcers. (Grade 2 recommendation; Level of evidence C)
21.1.1.7 Compression
• In a patient with a venous leg ulcer, we recommend compression therapy over no
compression therapy to increase venous leg ulcer healing rate. (Grade 1 recommendation; Level of evidence A)
• In a patient with a healed venous leg ulcer, we suggest compression therapy to
decrease the risk of ulcer recurrence. (Grade 2 recommendation; Level of
evidence B)
• We suggest the use of multicomponent compression bandage over single-
component bandages for the treatment of venous leg ulcers. (Grade 2 recommendation; Level of evidence B)
• In a patient with a venous leg ulcer and underlying arterial disease, we do not
suggest compression bandages or stockings if the ankle-brachial index is 0.5 or
less or if absolute ankle pressure is less than 60mm Hg. (Grade 2 recommendation; Level of evidence C)
• We suggest use of intermittent pneumatic compression when other compression
options are not available, cannot be used, or have failed to aid in venous leg ulcer
healing after prolonged compression therapy. (Grade 2 recommendation; Level
of evidence C)
21 Venous Leg Ulcers
21.1.2 European Society forVascular Surgery
The European Society for Vascular Surgery (ESVS) 2022 Clinical Practice
Guidelines on the Management of Chronic Venous Disease of the Lower Limbs [2]
recommend:
21.1.2.1 Recommendation 67
For patients with active venous leg ulceration without infection, the use of local or
systemic antibiotics to improve ulcer healing is not recommended. (Class III recommendation; Level of evidence B).
21.1 Guidelines
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21.1.2.2 Recommendation 68
For patients with active leg ulceration, objective arterial assessment is recommended. (Class I recommendation; Level of evidence C).
21.1.2.3 Recommendation 69
For patients with active venous leg ulceration, compression therapy is recommended
to improve ulcer healing (Class I recommendation; Level of evidence A).
21.1.2.4 Recommendation 70
For patients with active venous leg ulceration, multilayer or inelastic bandages or
adjustable compression garments, exerting a target pressure of at least 40mmHg at
the ankle, are recommended to improve ulcer healing. (Class I recommendation;
Level of evidence A).
21.1.2.5 Recommendation 71
For patients with active venous leg ulceration, superimposed elastic compression
stockings exerting a target pressure up to 40mmHg at the ankle should be considered for small and recent onset ulcers. (Class IIa recommendation; Level of evidence B).
21.1.2.6 Recommendation 72
For patients with active venous leg ulceration, with ankle pressure less than
60mmHg, toe pressure less than 30mmHg, or ankle brachial index lower than 0.6,
sustained compression therapy is not recommended. (Class III recommendation;
Level of evidence C).
21.1.2.7 Recommendation 73
For patients with active venous leg ulceration, intermittent pneumatic compression
should be considered when other compression options are not available, cannot be
used, or have failed to promote ulcer healing. (Class IIa recommendation; Level of
evidence B).
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21 Venous Leg Ulcers
21.1.2.8 Recommendation 74
For patients with a mixed ulcer caused by coexisting arterial and venous disease,
modied compression therapy under close clinical supervision, with a compression
pressure less than 40 mmHg may be considered, provided the ankle pressure is
higher than 60mmHg. (Class IIb recommendation; Level of evidence C).
21.1.2.9 Recommendation 75
For patients with healed venous leg ulceration, long term compression therapy
should be considered to reduce the risk of ulcer recurrence. (Class IIa recommendation; Level of evidence B).
21.1.2.10 Recommendation 76
For patients with active venous leg ulceration and supercial venous incompetence,
early endovenous ablation is recommended to accelerate ulcer healing. (Class I recommendation; Level of evidence B).
21.1.2.11 Recommendation 77
For patients with supercial venous incompetence and healed venous leg ulceration,
treatment of the incompetent veins is recommended to reduce the risk of ulcer
recurrence. (Class I recommendation; Level of evidence A).
21.1.2.12 Recommendation 78
For patients with active venous leg ulceration, ablation of the sub-ulcer venous
plexus using ultrasound guided foam sclerotherapy should be considered as part of
the treatment strategy. (Class IIa recommendation; Level of evidence C).
21.1.2.13 Recommendation 79
For patients with supercial venous incompetence and active or healed venous leg
ulceration, treatment of incompetent supercial veins is recommended, even in the
presence of deep venous incompetence. (Class I recommendation; Level of evidence A).
21.2 Results
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21.1.2.14 Recommendation 80
For patients with active venous leg ulceration as a result of supercial venous
incompetence and perforating vein incompetence close to the ulcer, concomitant
treatment of both truncal reux and incompetent perforators may be considered.
(Class IIb recommendation; Level of evidence C).
21.1.2.15 Recommendation 81
For patients with active or healed venous leg ulceration and iliac vein outow
obstruction, venous stenting should be considered. (Class IIa recommendation;
Level of evidence B).
21.1.2.16 Recommendation 82
For patients with active venous leg ulceration, micronized puried avonoid fraction, hydroxyethylrutosides, pentoxifylline, or sulodexide should be considered, as
an adjunct to compression and local wound care to improve ulcer healing. (Class IIa
recommendation; Level of evidence A).
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21.2 Results
21.2.1 Randomized Studies
21.2.1.1 Early Endovenous Ablation inVenous Ulceration
Although compression therapy improves venous ulcer healing, it does not treat the
underlying causes of venous hypertension. Gohel et al. [3] performed the Early
Venous Reux Ablation (EVRA) trial to evaluate the role of early endovenous treatment of supercial venous reux as an adjunct to compression therapy in patients
with venous leg ulcers. In this trial, 450 patients with venous leg ulcers were randomly assigned to receive compression therapy and undergo early endovenous ablation of supercial venous reux within 2 weeks after randomization
(early-intervention group) or to receive compression therapy alone, with consideration of endovenous ablation deferred until after the ulcer was healed or until
6 months after randomization if the ulcer was unhealed (deferred-intervention
group). The time to ulcer healing was shorter in the early-intervention group than in
the deferred intervention group; more patients had healed ulcers with early
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intervention (hazard ratio for ulcer healing, 1.38; 95% condence interval [CI],1.13
to 1.68; P= 0.001). The median time to ulcer healing was 56 days in the earlyintervention group and 82days in the deferred-intervention group. The rate of ulcer
healing at 24weeks was 85.6% in the early-intervention group and 76.3% in the
deferred- intervention group. The median ulcer-free time during the rst year after
trial enrollment was 306days in the early-intervention group and 278days in the
deferred-intervention group (P= 0.002). Early endovenous ablation of supercial
venous reux resulted in faster healing of venous leg ulcers and more time free from
ulcers than deferred endovenous ablation. Gohel etal. [4] performed an health economic evaluation of the EVRA trial and estimated costs and quality-adjusted life
years (QALYs) from the perspective of the UK National Health Service and Personal
Social Services over a 3-year time horizon. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. At
3years, early intervention was 91.6% likely to be cost-effective at a willingness to
pay £20,000 ($26,283) per quality-adjusted life year and 90.8% likely at a threshold
of £35,000 ($45,995) per quality-adjusted life year.
21 Venous Leg Ulcers
21.2.2 Meta-Analyses
21.2.2.1 Compression Bandages or Stockings forTreating Venous
Leg Ulcers
In a Cochrane review, Shi etal. [5] assessed the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg
ulcers in any setting and population. 14 studies (1391 participants) were included in
the review. There is moderate-certainty evidence that there is probably a shorter time
to complete healing of venous leg ulcers in people wearing compression bandages or
stockings compared with those not wearing compression over a 12-month follow-up
(ve studies with 733 participants); and that people treated with compression bandages or stockings probably have more completely healed venous leg ulcers during
follow-up to 12months than people not using compression (10 studies with 1215
participants). Moderate-certainty evidence suggests that the use of compression bandages or stockings probably reduces pain compared with no compression (ve studies with 859 participants and 69 ulcers in other participants). If using compression
bandages or stockings, people with venous leg ulcers probably experience complete
wound healing more quickly, and more people have wounds completely healed.
21.2.2.2 Dressings andTopical Agents forTreating Venous Leg Ulcers
Norman etal. [6] assessed the effects of dressings and topical agents for healing
venous leg ulcers in any care setting. 78 RCTs (7014 participants) were included in
this Cochrane review. The two most highly-ranked treatments both had more than
21.2 Results
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50% probability of being the best (sucralfate and silver dressings). However, the
data for sucralfate was from one small study, which means that this nding should
be interpreted with caution. When exploring the data for silver and sucralfate compared with widely-used dressing classes, there was some evidence that silver dressings may increase the probability of venous leg ulcer healing, compared with
nonadherent dressings: RR 2.43, 95% CI 1.58 to 3.74 (moderate-certainty evidence
in the context of a low-certainty network). For all other combinations it was unclear
whether the intervention increased the probability of healing.
The effects of hydrogel wound dressings on the healing of venous leg ulcers in
any care setting were assessed by Ribeiro etal. [7] in a Cochrane review. Four RCTs
(10 articles) were included in a qualitative analysis. Overall, 272 participants were
randomized, in sample sizes ranging from 20 to 156 participants. No studies provided evidence for the outcomes: recurrence of ulcer, health-related quality of life,
pain and costs. There is inconclusive evidence to determine the effectiveness of
hydrogel dressings compared with gauze and saline, alginate dressing, manuka
honey or hydrocolloid on venous leg ulcer healing. Practitioners may, therefore,
consider other characteristics such as costs and symptom management when choosing between dressings.
21.2.2.3 Growth Factors forTreating Chronic Venous Leg Ulcers
Lee etal. [8] evaluated the impact of growth factor treatments of venous leg ulcers
in comparison to control for complete wound healing, percent reduction in wound
area, time to wound healing, and adverse events. Of 13 studies with a total of 991
patients randomized to either a growth factor group or a control group, 960 patients
were included in the nal analysis of this review and meta-analysis. There was a
signicant difference between any growth factor and placebo in complete wound
healing (P=0.04). Any growth factor compared to placebo signicantly increased
the likelihood of percent wound reduction by 48.80% (P=<0.00001). There was no
difference in overall adverse event rates. This meta-analysis suggested that growth
factors have a benecial effect in complete wound healing of venous leg ulcers.
Growth factors may also increase percent reduction in wound area. The suggestion
of benet for growth factors identied in this review was of low quality of evidence.
Publication bias was strongly suspected, and trials generally had small sample sizes,
with only three trials randomizing 100 patients or more.
The weak evidence regarding the benet of growth factors for treatment of
venous leg ulcers is conrmed by Carvalho etal. [9]. They included 802 patients
from 10 studies in a meta-analysis, 472in the intervention group (application of
growth factors) and 330 as control. The relative risk for the complete healing outcome was 1.06 [95% CI 0.92–1.22], p= 0.41. Participants who received PlateletRich Plasma and Epidermal Growth Factor showed a slight tendency to achieve
complete healing, but without statistical relevance. Most of the studies were classied as moderate risk of bias.
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21 Venous Leg Ulcers
21.2.2.4 Wound Cleansing forTreating Venous Leg Ulcers
McLain etal. [10] assessed the effects of wound cleansing, wound cleansing solutions and wound cleansing techniques for treating venous leg ulcers. Four studies
with a total of 254 participants were included in this Cochrane review. All studies
included comparisons between different types of cleansing solutions, and three of
these reported complete wound healing or change in ulcer size over time, or both.
Studies that compared cleansing with no cleansing were not identied. From the
four studies identied, there is insufcient evidence to demonstrate whether the use
of polyhexamethylene biguanide (PHMB) solution compared with saline solution;
aqueous oxygen peroxide compared with sterile water; propyl betaine and polihexanide compared with a saline solution; or octenidine dihydrochloride/phenoxyethanol (OHP) compared with Ringer’s solution makes any difference in the
treatment of venous leg ulcers. Evidence from three of the studies is of very low
certainty, due to study limitations and imprecision. One study did not present data
for the primary or secondary outcomes. Further well-designed studies that address
important clinical, quality of life and economic outcomes may be important, based
on the clinical and patient priority of this uncertainty.
21.2.2.5 Medication
The clinical efcacy of sulodexide in patients with chronic venous disease was analyzed by Pompilio etal. [11] in a systematic review with meta-analysis. Randomized
trials were not available. However, the network meta-analysis suggested that sulodexide has the highest probability (48%) of being the most effective adjuvant treatment in increasing the healing rate of venous ulcers followed by pentoxifylline
(37%) and MPFF (16%). Sulodexide was at least as effective as pentoxifylline and
more effective than micronized puried avonoid fraction (MPFF) in improving the
rate of ulcer healing in patients with chronic venous disease. The authors therefore
recommended sulodexide as adjuvant therapy for chronic venous ulcers, with the
caveat that the evidence is limited.
Phlebotonics represent a heterogeneous group of medications used to treat
chronic venous insufciency (CVI). Most of these drugs are natural avonoids
extracted from plants. Synthetic products with avonoid-like properties are also
used to treat venous disorders. In the Anatomical Therapeutic Chemical (ATC) system, phlebotonics are classied as vasoprotective agents. A Cochrane review [12]
assessed the efcacy and safety of phlebotonics administered orally or topically for
treatment of signs and symptoms of lower extremity CVI.In total, 69 RCTs of oral
phlebotonics were included, but only 56 studies (7690 participants, mean age
50years) provided quantiable data for the efcacy analysis. These studies used
different phlebotonics (28 on rutosides, 11 on hidrosmine and diosmine, 10 on calcium dobesilate, two on Centella asiatica, two on aminaftone, two on French maritime pine bark extract and one on grape seed extract). No studies evaluating topical
phlebotonics, chromocarbe, naftazone or disodium avodate fullled the inclusion
References
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criteria. Moderate-certainty evidence suggested that phlebotonics probably reduce
oedema slightly in the lower legs, compared with placebo; and probably reduce
ankle circumference. Moderate-certainty evidence showed that phlebotonics probably make little or no difference in QoL compared with placebo; and similarly, may
have little or no effect on ulcer healing. Thirty-seven studies reported on adverse
events. Pooled data suggested that phlebotonics probably increase adverse events
slightly, compared to placebo. Gastrointestinal disorders were the most frequently
reported adverse events.
21.3 Conclusions forClinical Practice
1. Arterial pulse examination and measurement of ankle-brachial index on all
patients with venous leg ulcer is recommended.
2. For patients with active venous leg ulceration, multilayer or inelastic bandages
or adjustable compression garments, exerting a target pressure of at least
40mmHg at the ankle, are recommended to improve ulcer healing.
3. For patients with healed venous leg ulceration, long term compression therapy
should be considered to reduce the risk of ulcer recurrence.
4. For local wound care, selection of a primary wound dressing that will absorb
wound exudate produced by the ulcer (alginates, foams) and protect the periulcer
skin is recommended.
5. For patients with active venous leg ulceration and supercial venous incompe-
tence, early endovenous ablation is recommended to accelerate ulcer healing.
6. For patients with active or healed venous leg ulceration and iliac vein outow
obstruction, venous stenting should be considered.
7. For patients with active venous leg ulceration, micronized puried avonoid
fraction, hydroxyethylrutosides, pentoxifylline, or sulodexide should be considered, as an adjunct to compression and local wound care to improve ulcer
healing.
References
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Forum, etal. Management of venous leg ulcers: clinical practice guidelines of the Society for
Vascular Surgery ® and the American Venous Forum. J Vasc Surg. 2014;60(2 Suppl):3S–59S.
2. De Maeseneer MG, Kakkos SK, Aherne T, et al. Editor's choice—European Society for
Vascular Surgery (ESVS) 2022 clinical practice guidelines on the management of chronic
venous disease of the lower limbs. Eur J Vasc Endovasc Surg. 2022;63:184–267.
3. Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I,
Poskitt KR, Renton S, Warwick J, Davies AH, Trial Investigators EVRA.A randomized trial of
early endovenous ablation in venous ulceration. N Engl J Med. 2018;378:2105–14.
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4. Gohel MS, Mora MSc J, Szigeti M, Early Venous Reux Ablation Trial Group, etal. Longterm clinical and cost-effectiveness of early endovenous ablation in venous ulceration: a randomized clinical trial. JAMA Surg. 2020;155:1113–21.
5. Shi C, Dumville JC, Cullum N, Connaughton E, Norman G.Compression bandages or stockings versus no compression for treating venous leg ulcers. Cochrane Database Syst Rev.
2021;7(7):CD013397.
6. Norman G, Westby MJ, Rithalia AD, Stubbs N, Soares MO, Dumville JC.Dressings and topical agents for treating venous leg ulcers. Cochrane Database Syst Rev. 2018;6(6):CD012583.
7. Ribeiro CT, Dias FA, Fregonezi GA. Hydrogel dressings for venous leg ulcers. Cochrane
Database Syst Rev. 2022;8(8):CD010738.
8. Lee Y, Lee MH, Phillips SA, Stacey MC. Growth factors for treating chronic venous leg
ulcers: a systematic review and meta-analysis. Wound Repair Regen. 2022;30:117–25.
9. Carvalho MR, Silveira IA, Oliveira BGRB.Treatment of venous ulcers with growth factors:
systematic review and meta-analysis. Rev Bras Enferm. 2019;72:200–10. English, Portuguese
10. McLain NE, Moore ZE, Avsar P.Wound cleansing for treating venous leg ulcers. Cochrane
Database Syst Rev. 2021;3(3):CD011675.
11. Pompilio G, Nicolaides A, Kakkos SK, Integlia D. Systematic literature review and network meta-analysis of sulodexide and other drugs in chronic venous disease. Phlebology.
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12. Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, etal. Phlebotonics for venous insufciency. Cochrane Database Syst Rev. 2020;11(11):CD003229.
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