Valencia IC, Falabella A, Kirsner RS, Eaglstein WH.
Chronic venous insufficiency and venous leg ulceration.
J Am Acad Dermatol. 2001 Mar;44(3):401-21; quiz 422-4. doi: 10.1067/mjd.2001.111633.
Abstract/Text
UNLABELLED: Venous ulcers are the most common form of leg ulcers. Venous disease has a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Although the exact pathogenic steps leading from venous hypertension to venous ulceration remain unclear, several hypotheses have been developed to explain the development of venous ulceration. A better understanding of the current pathophysiology of venous ulceration has led to the development of new approaches in its management. New types of wound dressings, topical and systemic therapeutic agents, surgical modalities, bioengineered tissue, matrix materials, and growth factors are all novel therapeutic options that may be used in addition to the "gold standard," compression therapy, for venous ulcers. This review discusses current aspects of the epidemiology, pathophysiology, clinical presentation, diagnostic assessment, and current therapeutic options for chronic venous insufficiency and venous ulceration. (J Am Acad Dermatol 2001;44:401-21.)
LEARNING OBJECTIVE: At the conclusion of this learning activity, participants should be familiar with the 3 main types of lower extremity ulcers and should improve their understanding of the epidemiology, pathogenesis, risk factors, clinical presentation, diagnostic assessment, and current therapies for chronic venous insufficiency and venous ulcers.
van Gent WB, Hop WC, van Praag MC, Mackaay AJ, de Boer EM, Wittens CH.
Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial.
J Vasc Surg. 2006 Sep;44(3):563-71. doi: 10.1016/j.jvs.2006.04.053.
Abstract/Text
BACKGROUND: The prevalence of venous leg ulcers is as high as 1% to 1.5%, and the total costs of this disease are 1% of the total annual health care budget in Western European countries. Treatment modalities are conservative or surgical. Subfascial endoscopic perforating vein surgery (SEPS) combined with superficial vein ligation is performed in many centers to address vein incompetence in patients with chronic venous leg ulcers. Several reports describe good healing and low recurrence rates, although a randomized trial to compare surgical treatment including SEPS and treatment of the superficial venous system to conservative modalities has never been performed. Therefore, a prospective, randomized, multicenter trial was conducted to study whether ambulatory compression therapy with venous surgery is a better treatment than just ambulatory compression therapy in venous leg ulcer patients.
METHODS: Patients with an active (open) venous leg ulcer (CEAP C6) qualified for the study. The study consisted of two treatment groups. All patients were treated by standardized ambulatory compression therapy, and half of the patients received SEPS. Concomitant superficial venous incompetence was also treated in the second group. For allocation to both treatment groups, each patient was assigned by a computer program at the randomization center. The primary goal of the study was to compare the ulcer-free period during follow-up in both study groups. Secondary end points were ulcer healing and recurrence rates.
RESULTS: From April 1997 until January 2001, 200 ulcerated legs (170 patients) were included in the study in 12 centers in The Netherlands. A total of 97 ulcers were allocated to the surgical group and 103 to the conservative group. Patient characteristics were similar in the two treatment groups at baseline, with the exception of a higher proportion in the conservative group of diabetes mellitus. Healing rates were 83% in the surgical group and 73% in the conservative group (not significant; median time to healing, 27 months). Recurrence rates were the same in both treatment groups (22% surgical vs 23% conservative). During follow-up of a mean of 29 months (median, 27 months) in the surgical group and 26 months (median, 24 months) in the conservative group, we found that in the surgical group, the ulcer-free rate was 72%, whereas in the conservative group this rate was 53% (P = .11; Mann-Whitney test). Patients with recurrent ulceration or medially located ulcers in the surgical group had a longer ulcer-free period than those treated in the conservative group (P = .02 for both). A first-time ulcer and one of the centers also had a positive effect on the ulcer-free period during follow-up (P < .001 and P = .02), independent of the treatment group. Deep vein incompetence did not affect the ulcer-free period.
CONCLUSIONS: In conclusion, we suggest that patients with medial and/or recurrent ulceration should receive surgery combined with ambulatory compression therapy. A dedicated center should provide care for those patients.
Fletcher A, Cullum N, Sheldon TA.
A systematic review of compression treatment for venous leg ulcers.
BMJ. 1997 Sep 6;315(7108):576-80. doi: 10.1136/bmj.315.7108.576.
Abstract/Text
OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers.
METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted.
MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period.
STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers.
RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems.
CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.
Palfreyman S, Nelson EA, Michaels JA.
Dressings for venous leg ulcers: systematic review and meta-analysis.
BMJ. 2007 Aug 4;335(7613):244. doi: 10.1136/bmj.39248.634977.AE. Epub 2007 Jul 13.
Abstract/Text
OBJECTIVE: To review the evidence of effectiveness of dressings applied to venous leg ulcers.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Hand searches of journals and searches of electronic databases, conference proceedings, and bibliographies up to April 2006; contacts with dressing manufacturers for unpublished studies.
STUDIES REVIEWED: All randomised controlled trials that evaluated dressings applied to venous leg ulcers were eligible for inclusion. Data from eligible studies were extracted and summarised independently by two reviewers using a data extraction sheet. Methodological quality was assessed independently by two reviewers.
RESULTS: The search strategy identified 254 studies; 42 of these fulfilled the inclusion criteria. Hydrocolloids were no more effective than simple low adherent dressings used beneath compression (eight trials; relative risk for healing with hydrocolloid 1.02, 95% confidence interval 0.83 to 1.28). For other comparisons, insufficient evidence was available to allow firm conclusions to be drawn. None of the dressing comparisons showed evidence that a particular class of dressing healed more ulcers. Some differences existed between dressings in terms of subjective outcome measures and ulcer healing rates. The results were not affected by the size or quality of trials or the unit of randomisation. Insufficient data were available to allow conclusions to be drawn about the relative cost effectiveness of different dressings.
CONCLUSIONS: The type of dressing applied beneath compression was not shown to affect ulcer healing. The results of the meta-analysis showed that applying hydrocolloid dressings beneath compression produced no benefit in terms of ulcer healing compared with applying simple low adherent dressings. No conclusive recommendations can be made as to which type of dressing is most cost effective. Decisions on which dressing to apply should be based on the local costs of dressings and the preferences of the practitioner or patient.
Puggina J, Sincos IR, Campos W Jr, Porta RMP, Dos Santos JB, De Luccia N, Puech-Leão P, Collares FB, da Silva ES.
A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).
Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14.
Abstract/Text
OBJECTIVES: To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence.
METHOD: This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS).
RESULTS: Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT).
CONCLUSIONS: RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome.Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.
Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR.
Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial.
BMJ. 2007 Jul 14;335(7610):83. doi: 10.1136/bmj.39216.542442.BE. Epub 2007 Jun 1.
Abstract/Text
OBJECTIVE: To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression.
DESIGN: Randomised controlled trial.
SETTING: Specialist nurse led leg ulcer clinics in three UK vascular centres.
PARTICIPANTS: 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux.
INTERVENTIONS: Compression alone or compression plus saphenous surgery.
MAIN OUTCOME MEASURES: Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time.
RESULTS: Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test).
CONCLUSION: Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN07549334 [controlled-trials.com].
Chan SSJ, Yap CJQ, Tan SG, Choke ETC, Chong TT, Tang TY.
The utility of endovenous cyanoacrylate glue ablation for incompetent saphenous veins in the setting of venous leg ulcers.
J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):1041-1048. doi: 10.1016/j.jvsv.2020.01.013. Epub 2020 Mar 21.
Abstract/Text
OBJECTIVE: Patients with venous leg ulcers (VLUs) represent the worse spectrum of chronic venous insufficiency (CVI). The Early Venous Reflux Ablation (EVRA) landmark trial published in 2018 demonstrated that early endovenous intervention results in faster healing of VLUs. We describe our post-EVRA experience using endovenous cyanoacrylate glue ablation (ECGA) to treat superficial venous reflux on an early basis and assess its efficacy and safety in the setting of VLUs.
METHODS: There were 37 patients (39 legs, 43 truncal veins) with 43 discrete venous ulcers who underwent ECGA for CVI symptoms and VLUs. They received compression therapy and regular dressings for the VLUs postoperatively and were reviewed at 1 week, 3 months, 6 months, and 12 months after the procedure. Postoperative healing time for VLUs and complications were recorded along with the patient's satisfaction and postprocedure pain scores.
RESULTS: The venous ulcers were all <30 cm2 before ECGA. The mean time for VLU healing from operation was 73.6 ± 21.9 days, and the primary occlusion rate of the CVI at both 1 week and 3 months was 100%. No major adverse events were observed except for one case of deep venous thrombosis. There was significant improvement in the revised Venous Clinical Severity Score postoperatively from 11 ± 1.63 (baseline) to 5.6 ± 1.37 (P < .001) at 3-month follow-up (on a scale of 0 to 27, with the severity of symptoms at a maximal 27). The visual analog scale scores for pain were low postoperatively, decreasing from a preoperative score of 6.84 ± 1.42 to 2.72 ± 1.59 (P < .001) at the 3-month follow-up (on a scale of 1-10, with 10 being the most severe pain). The median time to return to normal activities was 7 days (interquartile range, 5-7 days).
CONCLUSIONS: ECGA together with compression therapy for VLUs is both safe and effective in this population of Asian patients. ECGA for patients with VLUs has excellent patient acceptability, minimal morbidity, and low recanalization rates at 12 months. Larger extensive studies and longer follow-up periods are required to validate the preliminary outcomes of this paper, and if it is proven to significantly improve ulcer healing rates, this will change the way we approach chronic venous ulceration.
Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
Baldursson BT, Hedblad MA, Beitner H, Lindelöf B.
Squamous cell carcinoma complicating chronic venous leg ulceration: a study of the histopathology, course and survival in 25 patients.
Br J Dermatol. 1999 Jun;140(6):1148-52. doi: 10.1046/j.1365-2133.1999.02879.x.
Abstract/Text
We have studied 25 cases of squamous cell carcinoma in chronic venous leg ulcers. Twenty-three of the patients were dead and two were alive. The mean age at cancer diagnosis was 78.5 years. The median survival was 1 year. Eleven tumours were well-differentiated, 10 moderately and four poorly. All patients with a poorly differentiated tumour died within a year. Metastases were certain in eight cases. The disease was lethal in 10 cases which included all poorly differentiated tumours. The survival of the study group was significantly shortened compared with a control group of patients with lower limb non-melanoma skin cancer (n = 433) from the Swedish Cancer Registry (P = 0.0084). When diagnosed, squamous cell carcinoma in chronic leg ulcers merits a thorough investigation of the degree of differentiation and spread. Assertive treatment is indicated as poorly differentiated tumours and some moderately differentiated tumours may be fatal.
Wilson CL, Cameron J, Powell SM, Cherry G, Ryan TJ.
High incidence of contact dermatitis in leg-ulcer patients--implications for management.
Clin Exp Dermatol. 1991 Jul;16(4):250-3. doi: 10.1111/j.1365-2230.1991.tb00368.x.
Abstract/Text
A retrospective review of patch test results from all new patients with venous leg ulcers was performed for the preceding 11 months. Eighty one patients referred from general practitioners and district nurses with venous stasis ulcers were included. Positive patch tests were found in 54 patients (67%), including a continued high incidence of allergy to lanolin and topical antibiotics. Multiple allergies were found in 48 patients (58%). In addition, a new problem of allergy to cetearyl alcohol, a constituent of commonly used creams and paste bandages, was identified in 13 patients. There is a continuing high incidence of contact sensitivity in patients with venous stasis ulcers which has important implications for the management of these patients.
