Ablation length, not modality type, determines healing outcomes in venous leg ulcers

Factors that influence venous leg ulcer healing and recurrence rate after endovenous radiofrequency ablation of incompetent saphenous vein

Objective: We aimed to study venous leg ulcer (VLU) healing and recurrence rates of VLU using a self-care-based treatment strategy.Methods: The study included 36 patients (43 legs) who visited our clinic between April 2009 and June 2015 because of non-healing VLUs and who had been treated by us for more than a year (until June 2016). Patients or their caregivers were first provided instructions for performing the “no-intentional-stretch” bandaging technique using ordinary elastic bandages. Wounds were cleansed with tepid water daily, and bandages were re-applied by patients or their caregivers; this was continued until VLUs were healed. Compression was discontinued after healing, but was restarted if persistent swelling and/or dermatitis was noticed on their legs.Results: The median ulcer size was 6.5 cm2 (range, 1–105 cm2). The median number of clinic visits until healing was six (range, 3–35). The 6- and 12-month healing rates were 67% and 86%, respectively. Twenty (44%) legs required compression therapy after VLU healing. The cumulative recurrence-free rate at 60 months was 86%.Conclusion: Reasonable healing and recurrence rates were achieved by applying a self-care-based VLU treatment strategy.

Recurrence of venous leg ulceration

Chronic venous ulcer healing is a complex clinical problem that requires intervention from skilled, costly, multidisciplinary wound-care teams. Compression therapy has been shown to help heal venous ulcers and to reduce the risk of recurrence. It is not known which interventions help people adhere to compression treatments. To assess the benefits and harms of interventions designed to help people adhere to venous leg ulcer compression therapy, and thus improve healing of venous leg ulcers and prevent their recurrence after healing. In May 2013 we searched The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; trial registries, and reference lists of relevant publications for published and ongoing trials. There were no language or publication date restrictions. We included randomised controlled trials (RCTs) of interventions that help people with venous leg ulcers adhere to compression treatments compared with usual care, or no intervention, or another active intervention. Our main outcomes were number of people with ulcers healed, recurrence, time to complete healing, quality of life, pain, adherence to compression therapy and number of people with adverse events. Two review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial, and assessed overall quality of evidence for the main outcomes in 'Summary of findings' tables. Low quality evidence from one trial (67 participants) indicates that, compared with home-based care, a community-based Leg Club® clinic that provided mechanisms for peer-support, assistance with goal setting and social interaction did not result in superior healing rates at three months (12/28 people healed in Leg Club clinic group versus 7/28 in home-based care group; risk ratio (RR) 1.71, 95% confidence interval (CI) 0.79 to 3.71); or six months (15/33 healed in Leg Club group versus 10/34 in home-based care group; RR 1.55, 95% CI 0.81 to 2.93); or in improved quality of life outcomes at six months (MD 0.85 points, 95% CI -0.13 to 1.83; 0 to 10 point scale). However, the Leg Club resulted in a statistically significant reduction in pain at six months (MD -12.75 points, 95% CI -24.79, -0.71; 0 to 100 point scale), although this was not considered a clinically important difference. Time to complete healing, recurrence of ulcers, adherence and adverse events were not reported.Low quality evidence from another trial (184 participants) indicates that, compared with usual care in a wound clinic, a community-based and nurse-led self-management programme of six months' duration promoting physical activity (walking and leg exercises) and adherence to compression therapy via counselling and behaviour modification (Lively Legs®) may not result in superior healing rates at 18 months (51/92 healed in Lively Legs group versus 41/92 in usual care group; RR 1.24 (95% CI 0.93 to 1.67)); may not result in reduced rates of recurrence of venous leg ulcers at 18 months (32/69 with recurrence in Lively Legs group versus 38/67 in usual care group; RR 0.82 (95% CI 0.59 to 1.14)); and may not result in superior adherence to compression therapy at 18 months (42/92 people fully adherent in Lively Legs group versus 41/92 in usual care group; RR 1.02 (95% CI 0.74 to 1.41)). Time to complete healing, quality of life, pain and adverse events were not reported. We found no studies that investigated other interventions to promote adherence to compression therapy. There is a paucity of trials of interventions that promote adherence to compression therapy for venous ulcers. Low quality evidence from two trials was identified: one promoting adherence via socialisation and support (Leg Club®), and the other promoting adherence to compression, leg exercises and walking via counselling and behaviour modification (Lively Legs®).These trials did not reveal a benefit of community-based clinics over usual care in terms of healing rates, prevention of recurrence of venous leg ulcers, or quality of life. One trial indicated a small, but possibly clinically unimportant, reduction in pain, while adverse events were not reported. The small number of participants may have a hidden real benefit, or an increase in harm. Due to the lack of reliable evidence, at present it is not possible either to recommend or discourage nurse clinic care interventions over standard care.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study

Venous leg ulcers (VLUs) are a health problem in clinical care. Several options can be employed as adjuvant to standard treatment. We have aimed to analyze the effect of standard ulcer care alone with high-frequency ultrasound (HFU) and MIST ultrasound therapy on VLUs. Ninety patients with VLUs were assigned into the standard treatment, HFU and MIST ultrasound groups. All groups received the standard wound care. In the ultrasound groups, HFU and MIST ultrasound therapy was administered to wounds 3 times per week until the wound healed. Time of complete wound healing was recorded. Wound size, pain, and edema were assessed at baseline and after 2 and 4 months. Also, patients were instructed to contact our clinic monthly, and recurrence of VLUs was recorded for 6 months after complete wound healing. The data was analyzed using a Student's t-test, ANOVA, c2, or Fisher's exact test. P<0.05 was considered significant. Mean time duration of complete wound healing in the first, second and third groups was 8.13 (SD 1.40), 6.10 (SD 1.47) and 5.70 (SD 1.57) months, respectively (p<0.0001). Size of ulcer, mean degree of pain and edema in ultrasound therapy was decreased after the 4-month visit in comparison to the standard-treatment group (p=0.01, p<0.0001 and p<0.0001, respectively). Also, our results don't show any significant differences between groups in the recurrence of VLUs during a 6-month follow up after complete wound healing (p=0.37). Our results in the present study show the significant effectiveness of ultrasound therapy in wound healing. Differences between the two ultrasound therapy groups were not statistically significant.

Following the healing of venous leg ulcers, the primary problems for nursing and patients are adhering to compression therapy and preventing ulcer recurrence. As a result, it is important that patients comprehend their situation. The purpose of this study is to see how an educational nursing intervention affected compression therapy adherence and recurrence of venous leg ulcers in patients with chronic venous leg ulcers. A quasi-experimental design was used, including an intervention, a control group, and before and after assessments. This study was conducted in one of Egypt’s largest teaching hospitals associated with Menoufia University. The 20-month study included 80 adult patients with healed venous leg ulcers. Each participant was randomized to either a control (got regular leg ulcer information) or study (received educational interventions) group. The following tools were used in the study: bio-sociodemographic variables, knowledge evaluation, compression therapy adherence scale, and recurrence follow-up, after 3, 6, and 12 months of implementation. Furthermore, there is a statistically significant difference between the study groups during the pretest (r = 0.885, 0.774, and 0.477, p = 0.002). The use of nursing education increased patients’ understanding and adherence to compression treatment substantially. As a consequence, those with chronic venous leg ulcers may be able to avoid recurrent venous leg ulcers.

Leg ulcer treatment

IntroductionVenous leg ulcers (VLU) are the most severe manifestation of venous insufficiency and carry a poor prognosis because of delayed healing and recurrent ulceration. Pentoxifylline (PTX) is an example of a vasoactive medication that can be used alongside compression therapy to help improve ulcer healing rates. A previous review highlighted improved healing of VLU with PTX, although no analysis was made for complete ulcer healing and recurrence following treatment.MethodsA systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The EMBASE, MEDLINE and Cochrane databases were searched for all relevant English-language human studies between January 1980 and August 2023. Two independent authors screened and reviewed all articles for inclusion, performed data extraction and assessed methodological quality according to Cochrane’s risk of bias tool. Primary outcomes included complete ulcer healing and recurrence rates in the ipsilateral limb.ResultsTen studies were eligible for analysis, of which nine were randomised trials and one was an observational cohort study. There were a total of 1,025 participants, with 515 having received PTX. In those receiving 1200 mg PTX, venous leg ulcers healed in 62% (315 participants). Compared to controls, PTX administration was associated with a significantly higher likelihood of complete ulcer healing (OR 2.56, 95% CI 1.97-3.32, p < .001). The rate and time of ulcer recurrence were not recorded in any of the studies included.ConclusionThe evidence demonstrates that PTX may have a significant beneficial impact on the rate of complete ulcer healing. Little evidence is currently present in the literature evaluating the recurrence rates of ulcers following PTX treatment. Large scale, high quality RCTs with an adequate follow-up period are needed to evaluate this and assess whether treatment with PTX shows a significant benefit in prevention of recurrence in venous ulcers.

Oral aspirin for treating venous leg ulcers.

Risk factors for the recurrence of venous leg ulcers in adults: A systematic review protocol

1. Co-chaired this panel2. University of South Florida, Tampa, FL3. Healthpoint Ltd., Fort Worth, TX4. University of California, San Francisco, CA5. University of Texas Medical Branch, Galveston, TX6. University of Cardiff, Cardiff, Wales, UK7. University of Pennsylvania, Philadelphia, PA8. Private practice, Warren, PA9. Private practice, Tamarac, FL10. University of Pittsburgh, Pittsburgh, PA11. St. Louis University, St. Louis, MO, and12. Washington University, St. Louis, MO

Most leg ulcers are caused by venous disease, the most common cause of venous hypertension being superficial vein incompetence. The ESCHAR trial tested the value of superficial vein surgery combined with compression in the healing and recurrence of venous leg ulcers compared with compression alone. A total of 500 patients with chronic venous leg ulcers, or recently healed ulcers, were randomized to superficial vein surgery and compression or compression alone. Vein surgery was saphenofemoral ligation and great saphenous stripping and phlebectomy or saphenopopliteal ligation and phlebectomy. Ulcer healing was virtually identical between the 2 groups at 65% at 24 weeks; subgroup analysis failed to show a benefit for surgery to promote ulcer healing. Ulcer recurrence rate was halved in those that underwent surgery regardless of the presence of deep vein incompetence. Superficial vein surgery should be considered in all leg ulcer sufferers to reduce ulcer recurrence rather than accelerate ulcer healing.

ObjectiveNational guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported. MethodsThe review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis. ResultsAfter screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms. ConclusionsA paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.

Gohel etal. aimed to compare early endovenous ablation vs. deferred endovenous ablation of superficial venous reflux with regard to time to healing of venous leg ulcers, rate of healing at 24 weeks, recurrence rate, ulcer-free time and health-related quality of life. This multicentre, parallel-group (ratio 1:1), randomized controlled trial was conducted in a vascular surgery department setting at 20 participating centres across the U.K. A total of 450 patients with venous leg ulcers were randomly assigned to receive compression therapy and undergo early endovenous ablation of superficial venous reflux 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 primary outcome was the time to ulcer healing. Secondary outcomes were the rate of ulcer healing at 24 weeks, the rate of ulcer recurrence, the length of time free from ulcers (ulcer-free time) during the first year after randomization, and patient-reported health-related quality of life. Endovenous laser or radiofrequency ablation, ultrasound-guided foam sclerotherapy, or nonthermal, nontumescent methods of treatment (such as cyanoacrylate glue or mechanochemical ablation) were performed either alone or in combination. The treating clinical team determined the method and strategy of endovenous treatment. The time to ulcer healing was shorter in the early-intervention group than in the deferred-intervention group. Furthermore, more patients had healed ulcers with early intervention [hazard ratio for ulcer healing 1·38, 95% confidence interval (CI) 1·13-1·68; P = 0·001]. The median time to ulcer healing was 56 days (95% CI 49-66) in the early-intervention group and 82 days (95% CI 69-92) in the deferred-intervention group. The rate of ulcer healing at 24 weeks was 85·6% in the early-intervention group and 76·3% in the deferred-intervention group. The median ulcer-free time during the first year after trial enrolment was 306 days (interquartile range 240-328) in the early-intervention group and 278 days (interquartile range 175-324) in the deferred-intervention group (P = 0·002). The most common complications were pain and deep vein thrombosis (DVT) (early-intervention group: pain, six of 28; DVT, nine of 28; deferred-intervention group: pain, six of 24; DVT, three of 24). Gohel etal. conclude that early endovenous ablation of superficial venous reflux results in faster healing of venous leg ulcers than deferred endovenous ablation. Patients assigned to the early-intervention group also had longer ulcer-free time during the first year after randomization.