Treatment Of Venous Leg Ulcers Research Articles

Strategies and challenges in the treatment of chronic venous leg ulcers.

Evaluating patients with chronic venous leg ulcers (CVLUs) is essential to find the underlying etiology. The basic tenets in managing CVLUs are to remove the etiological causes, to address systemic and metabolic conditions, to examine the ulcers and artery pulses, and to control wound infection with debridement and eliminating excessive pressure on the wound. The first-line treatments of CVLUs remain wound care, debridement, bed rest with leg elevation, and compression. Evidence to support the efficacy of silver-based dressings in healing CVLUs is unavailable. Hydrogen peroxide is harmful to the growth of granulation tissue in the wound. Surgery options include a high ligation with or without stripping or ablation of the GSVs depending on venous reflux or insufficiency. Yet, not all CVLUs are candidates for surgical treatment because of comorbidities. When standard care of wound for 4 wk failed to heal CVLUs effectively, use of advanced wound care should be considered based on the available evidence. Negative pressure wound therapy facilitates granulation tissue development, thereby helping closure of CVLUs. Autologous split-thickness skin grafting is still the gold standard approach to close huge CVLUs. Hair punch graft appears to have a better result than traditional hairless punch graft for CVLUs. Application of adipose tissue or placenta-derived mesenchymal stem cells is a promising therapy for wound healing. Autologous platelet-rich plasma provides an alternative strategy for surgery for safe and natural healing of the ulcer. The confirmative efficacy of current advanced ulcer therapies needs more robust evidence.

Comparison of the efficacy of topical hyperbaric oxygen therapy alone vs a combination of physical methods including topical hyperbaric oxygen therapy, magnetotherapy, and low‐energy light therapy in the treatment of venous leg ulcers

The aim of the study was to compare the therapeutic efficacy of topical hyperbaric oxygen therapy alone vs a combination of physical methods including topical hyperbaric oxygen therapy, magnetotherapy and low-energy light therapy in the treatment of venous leg ulcers. Thirty-six patients were treated with topical oxygen hyperbaria and 29 patients were treated with a combination of physical methods. The assessment of ulcer surface area with use of a planimetric method, pain intensity with use of Laitinen scale and quality of life by means of EuroQol scale were performed. In both groups a statistically significant (P < .05) reduction of ulcer surface area has been obtained, but in patients treated with combined physical therapy average percentage reduction of ulcer surface area (36.44% ± 11.04%) was statistically significantly (P = .00001) bigger as compared to other group (13.65% ± 8.32%). In both groups of patients statistically significant (P < .05) reduction of frequency and intensity of pain, reduced intake of analgesic drugs and reduction of limitations of physical activity, as well as statistically significant improvement of quality of life have been observed, but in patients treated with combined physical therapy an average increase in the score in EuroQoL scale (61.03 ± 7.14) was statistically significantly (P = .00001) bigger as compared to other group (25.27 ± 8.16). It was concluded that topical hyperbaric oxygen therapy alone and a combination of physical methods cause significant reduction of ulcer surface area, reduction of pain intensity, as well as improvement of the quality of life, but a combination of physical methods is more efficient.

Association of autologous punch grafting, TLC-NOSF dressing and multitype compression therapy to rapidly achieve wound closure in hard-to-heal venous leg ulcers.

To document the efficacy of a combined therapeutic strategy in achieving rapid wound healing in patients with long-standing ulcers. Outpatients with hard-to-heal venous leg ulcers were included in an interventional, prospective, single-arm, mono-centre study and treated with autologous punch grafting, TLC-NOSF dressing and multi-type compression therapy. The primary outcome was the percentage of healed wounds by week 12. Secondary outcomes included time-to-reach wound closure, wound area reduction, treatment acceptability and safety. From November 2018 to October 2019, 42 patients with 51 ulcers were included (23 males, 70.6±40.8 years old, with multiple comorbidities). Despite poor wound healing prognosis at baseline (47% of recurrent ulcers, with a mean duration of 15 months and a mean area of 12.6cm2), wound healing was achieved in 47 ulcers (92%) after a mean period of treatment of 25±13 days. A relative wound area reduction>75% was also reached in three additional ulcers by the last evaluation visit. No adverse event related to the procedure was reported throughout the study period. The associated treatment were very well tolerated and accepted by the patients. The evaluated procedure induced fast re-epithelisation of the treated ulcers. Based on our experience, this simple and successful reparative strategy may be considered as an interesting option in the treatment of venous leg ulcers of poor prognosis.

Comparative Study of Long- and Short-Stretch Woven Compression Bandages

Abstract Compression therapy using bandages or socks is the most common treatment for venous leg ulcers and edema. This article aims to compare the compression between long- and short-stretch bandages (LSB and SSB, respectively). Load-elongation curves, cyclic loading, and elastic recovery are investigated for both Cotton/Polyamide/Polyurethane and 100% bleached cotton bandages as LSB and SSB, respectively. Static (resting) and dynamic (working) pressures are measured on seven male legs, 31 ± 3.6 years old, using both two and three layers bandaging. Picopress pressure tests are performed on the ankle and mid-calf positions at gradual decreasing compression from the ankle to the knee. The deviation percentage between the experimental results by Picopress and theoretical calculations using Laplace's law and Al-Khaburi equations is compared. LSB recovered approximately 99% of its original length after stress-relaxation whereas SSB recovered only 93% of its original length after 5 days of cyclic load-relaxation. Moreover, SSB lost approximately 28.6% of its activity after wearing on the human leg for 5 days.

A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).

To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. 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). 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). 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.

Silver dressings for the healing of venous leg ulcer: A meta-analysis and systematic review.

This study was aimed to evaluate whether silver-containing dressings were superior to other types of dressings in the treatment of venous leg ulcers (VLU) and their specific advantages.Eight databases (Cochrane Library, PubMed, Web of Science, Ovid-Medline, Wanfang, VIP, China Biology Medicine, and China National Knowledge Infrastructure) were systematically reviewed from inception to May 2019 for randomized controlled trials (RCTs). The primary outcome was complete wound healing, and the secondary outcomes included absolute wound size changes (change of cm2 area since baseline), relative changes (percentage change of area relative to baseline), and healing rate. Two reviewers independently evaluated the risk of bias using the Cochrane Collaboration assessment tool and extracted the data according to the predesigned table. All analyses were performed using the latest Review Manager Software (version 5.3).A total of 8 studies qualified and were included in the meta-analysis, including 1057 patients (experiment: 526, control: 531). Both complete wound healing and wound healing rates were reported in 5 studies. Two and 3 studies reported the effect of silver dressings on absolute and relative wound size changes, respectively. Most of the studies used intention-to-treat analysis.There was sufficient evidence that silver-containing dressings can accelerate the healing rate of chronic VLU and improve their healing in a short duration of time. However, compared with other dressings, clinical trials with long-term follow-up data are needed to confirm whether silver dressings have advantages regarding complete wound healing.

&lt;p&gt;Kikuhime Device in the Management of Venous Leg Ulcers&lt;/p&gt;

The effectiveness of compression therapy in the treatment of venous leg ulcers has been confirmed in many scientific studies. The healing process depends on many of its parameters, such as the type of compression bandages, their elastic properties and sub-bandage pressure. However, there is no standard protocol that would ensure success for all patients. A pressure of about 83 mmHg provides complete compression for both superficial and deep veins; however, applying compression bandages under such high pressure is a difficult task, even for experienced therapists. Here, we present the case of a 61-year-old woman with approximately 2.5-year-old venous ulcer in her left leg due to chronic venous insufficiency (CVI). Our study aimed to show that routine pressure control at each bandage renewal using the Kikuhime device, as well as their twice daily application in the first week of therapy reduced the healing time of a venous leg ulcer with an area of about 20 cm2 to four weeks.

Treatment of venous leg ulcers using bilayered living cellular construct.

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients' physical, functional and psychological status and reduce QoL. A total75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.

A dual compression system: preliminary clinical insights from the US.

There is growing evidence on an interconnection between the venous and lymphatic systems in venous leg ulceration, and the possible effects of prolonged oedema and lymphatic impairment in delayed wound healing. Compression therapy is a widely accepted treatment for venous and lymphatic disorders, as it decreases recurrence rates and prolongs the interval between recurrences. Compression bandages improve venous return, increase the volume and rate of venous flow, reduce oedema and stimulate anti-inflammatory processes. The pressure at the interface (IP) of the bandage and the skin is related to the elastic recoil of the product used and its resistance to expansion. The pressure difference between the IP in the supine and standing positions is called the static stiffness index (SSI). Elastic materials provide little resistance to muscle expansion during physical activity, resulting in small pressure differences between resting and activity, with an SSI <10mmHg. Stiff, inelastic materials with a stretch of <100% resist the increase of muscle volume during physical activity, producing higher peak pressures, an SSI of >10mmHg and a greater haemodynamic benefit than elastic systems. UrgoK2 is a novel dual-layer high-compression system consisting of an inelastic (short stretch) and elastic (long stretch) bandage, resulting in sustained tolerable resting pressure and elevated working pressures over extended wear times. It is indicated for the treatment of active venous leg ulcers and the reduction of chronic venous oedema. Each bandage layer has a visual aid to enable application at the correct pressure level. Published European studies have assessed this compression system, exploring its consistency of application, tolerability and efficacy. This article presents the first reports of health professionals' clinical experience of using the compression system in the US, where it has been recently launched. Initial feedback is promising.

Evaluation of safety and efficacy of autologous topical platelet gel vs platelet rich plasma injection in the treatment of venous leg ulcers: A randomized case control study.

Various management options were tried for Chronic venous leg ulcers (VLUs) with no satisfactory results. Platelet-rich plasma (PRP) is promising in enhancing chronic wound healing by releasing various growth factors. We evaluated the safety and efficacy of topical platelet gel (PG) vs PRP injection in treatment of venous leg ulcers. 20 patients were treated with topical PG (group I), 20 patients received PRP injection (group II), and 20 patients were treated with saline dressing and compression as controls (group III) weekly for 6 weeks. Ulcer improvement was evaluated by pressure ulcer scale for healing (PUSH). Histopathological evaluation and immunohistochemical staining using anti-CD34 were performed before and after treatment. There was significant improvement in PUSH score in group (I) and (II) compared to group (III; P value: .001). However, there was no statistically significant difference in improvement between group I and II (P value = .83). However, topical PG was more effective in diabetics and PRP was more effective in long standing fibrosed ulcers. Histopathology showed reduction of the inflammatory cells infiltrates and well-formed granulation tissue with no difference in immunostaining. So, both topical PG and PRP injection were effective, low cost, and safe procedures in enhancing healing of chronic VLUs.

Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU)

ObjectiveTo determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.DesignPragmatic parallel group randomised controlled trial.SettingCommunity-dwelling participants.ParticipantsPeople aged 18 or more years with...

Effect of different compression bandaging techniques on the healing rate of venous leg ulcers: a literature review.

Venous leg ulcers (VLUs) are a common health problem in older adults, for which the widely used method of treatment includes compression therapy. There are various compression bandages and hosiery systems available for use, but it remains unclear as to which types of compression systems are most effective in enabling healing of VLUs. This study aimed to determine which type of the two most commonly used compression bandaging (four-layer and two-layer) is more effective in providing complete ulcer healing of VLUs. Key search terms were identified using the PICO (population, intervention, comparison, outcome) model, with distinct inclusion and exclusion criteria, in a strategic search of electronic databases (e.g. CINAHL and MEDLINE) along with wider sources, including Google Scholar. More studies favoured the four-layer compression system than two-layer for providing better healing rates in the treatment of VLUs, but two-layer bandaging tends to provide a better quality of life and may be more cost-effective, although comorbidities and other factors also need to be considered. In choosing the type of compression bandage for the management of leg ulcers, the healing rate achieved by the chosen bandage needs to be carefully monitored, while also taking into consideration other factors such as the quality of life for the patient.

Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial

BackgroundLimb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. MethodsPatients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. ResultsThere were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). ConclusionsIn this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

A real-world experience with the bioactive human split thickness skin allograft for venous leg ulcers.

Data collected from standardized clinical practices can be valuable in evaluating the real-world therapeutic benefit of skin substitutes in the treatment of venous leg ulcers (VLU). Utilizing such a dataset, this study aimed to validate the effectiveness of a bioactive human split-thickness skin allograft for the treatment of VLU in the real-world setting and to understand how certain variables impacted healing rates. From a pool of 1474 VLU treated with allograft, 862 ulcers in 742 patients were selected from a large wound EMR database and analyzed. All patients received standard wound care prior to allograft application. Impact of ulcer duration, number of applications, ulcer size, and time to application were analyzed. The VLU, on average, were of 189 days duration with a mean ulcer size of 19.3 cm2 . During treatment, 70.7% of wounds healed, with an average time to closure of 15 weeks (SD = 14.1 weeks). The percentage of VLU less than one-year duration that healed was significantly higher (72.3%) than the percentage of VLU with duration of greater than 1 years (51.5%) ( χ2 = 18.17; P < .001). Ulcers less than 10 cm2 in size were more likely to heal (73.9%) than those larger than 10 cm2 (67.9%) ( χ2 = 8.65, P = .03). VLU receiving allograft within 90 days of initial presentation are 1.4 times more likely to heal vs those receiving their first BSA application after 90 days of standard of care (95% CI: [1.05, 1.86], P = .02). Allograft used in wound clinics healed a majority of refractory VLU, even in large ulcers of long duration, which are more difficult to heal. Smaller wound, size, and shorter wound duration were associated with greater likelihood of healing. VLUs treated earlier with allograft had better healing outcomes. Clinicians may consider more aggressive and timely treatment with allograft for refractory VLU.

The effect of natural matrix biopolymer membrane on hard-to-heal venous leg ulcers: a pilot randomised clinical trial.

The aim of this study was to evaluate the therapeutic effects of natural matrix biopolymer membrane (NMBM) in the treatment of venous leg ulcers (VLUs). Patients exhibiting one or more VLU were assigned to a test group receiving NMBM or to a control group receiving conventional treatment. Patients exhibiting venous insufficiency-related ulcers within 0.1-170cm2 were included. Efficacy was assessed based on ulcer size and visual analogue scale (VAS) pain scores at baseline and at weeks one, two and four. Ulcer size and pain were compared between groups using a two-way ANOVA. In this study, 25 patients with 32 VLUs (NMBM group: 14 patients with 17 ulcers; control group: 11 patients with 15 ulcers) were included in the final analysis. At four weeks after baseline measurements, the mean percentage change in VLU area of patients in the NMBM group was 61.6% (95% CI: 40.3-82.9) compared with 84.1% (95% CI: 56.5-111.7) for control group patients. Additionally, the mean percentage change in VLU volume of NMBM group patients was 51.2% (95% CI: 31.8-70.6) compared with 84.0% (95% CI: 57.0-121.0) for control group patients. The NMBM group patients exhibited a mean decrease of 0.38 (95% CI: -0.85-1.61) in VAS pain score over four weeks, compared with a mean decrease of 0.13 (95% CI: -1.32-1.58) for control group patients. No significant differences in VLU area (p=0.210), volume (p=0.122) or VAS pain score (p=0.460) were shown between groups. NMBM was found to be as effective and safe as the control group treatments. This pilot study suggests NMBM can be used safely to promote ulcer healing.

PCV1 A RETROSPECTIVE, COMPARATIVE EFFECTIVENESS ANALYSIS OF A BILAYERED LIVING CELLULAR CONSTRUCT AND AN ACELLULAR FETAL BOVINE COLLAGEN DRESSING FOR THE TREATMENT OF VENOUS LEG ULCERS

In a real-world, retrospective, comparative effectiveness research (CER) study design we evaluated a large venous leg ulcer (VLU) patient population comparing clinical outcomes using a bilayered living cellular construct (BLCC) versus an acellular fetal bovine collagen dressing (FBCD). Electronic medical records (WoundExpert, Net Health, PA, US) used by wound care facilities across the US were the source of these retrospective data. Data collected between 1/2015 and 1/2019 on 6,916 patients (9,552 VLUs) were analyzed. Ulcers 1-40 cm2 that closed ≤40% in the 4 weeks prior to treatment were included. Patients with no baseline wound measurements or follow-up visits were excluded. Evaluations were performed on 6,648 BLCC patients (9,270 VLUs), and 268 FBCD patients (282 VLUs). At baseline, median areas were 6.8 and 7.1 cm2, and median durations were 5.1 and 5.5 months, for BLCC and FBCD, respectively. A Cox analysis adjusting for key covariates including ulcer size and duration was conducted. The median time to closure was significantly faster for BLCC (18 weeks) when compared to FBCD (25 weeks), representing a 28% reduction (p=0.003). The frequency of wound closure for BLCC was significantly greater compared to FBCD by week 12 (35 vs 29%), 24 (54 vs 47%), and 36 (69 vs 52%) (p=0.003). Analyses of two de-identified insurance claims databases showed that VLU treatment costs were directly proportional to the frequency of and time to healing. Patients with non-healed VLUs had 78% more hospitalization days, 50% more emergency department visits, 27% more outpatient office visits, and 60% more days of home healthcare. Total healthcare costs were $537/week higher for patients with open VLUs. These data show that BLCC significantly improved the incidence and decreased the time to wound closure compared to FBCD suggesting that BLCC may provide significant cost savings for the treatment of VLUs.

Analysis of predicted full recovery time for venous leg ulcers treated with intermittent pneumatic compression.

IntroductionVenous leg ulcers are difficult-to-heal wounds. Reduction of venous hypertension and eradication of oedema is of key importance in the treatment of clinical symptoms of venous hypertension and venous leg ulcers. This can be done by using compression therapy in which external pressure is applied to the skin surface, giving a positive effect on the venous, lymphatic and arterial systems of macro- and microcirculation.AimAnalysis of full recovery predicted time for venous ulcers.Material and methodsThe purpose of our study was to rate the intermittent pneumatic compression (IPC) therapy in venous leg ulcers treatment. In the study group, the IPC therapy (pressure of 60 mm Hg at the ankle) was used – one treatment daily for 4 weeks. The changes of the total area, circumference, maximum length and maximum width of ulcers were measured. Then, based on the collected values, we calculated healing progress (Gilman index), healing rate, predicted healing time and non-linear approximation of the treatment time needed to decrease the ulcer surface area by 50% and then we compared them the treatment times.ResultsAnalysis of the results shows that a percentage change in the surface area in the treatment group was 52%. There was a statistically significant difference between the ulcer surface area before and after treatment (p < 0.05). There was no statistically significant difference between the healing rate in individual weeks of treatment (p > 0.05). The percentage reduction in circumferences of the lower limb showed a statistically significant advantage in the study group comparison baseline (p < 0.05).ConclusionsTreatment of venous leg ulcers with the IPC therapy is effective.

A randomized trial of surgery alone versus surgery plus compression in the treatment of venous leg ulcers in patients with primary venous insufficiency

Background/Aim.Venous leg ulcers (VLU) are a significant health problem worldwide. It is well known that VLU are difficult to treat and that they have high tendency for recurrence. Compression therapy is the preferred treatment modality but there is growing evidence that correction of underlying venous disorder in early stages of the disease in addition to compression treatment may improve ulcer healing and reduce recurrence rate. Methods. An open, prospective, randomized, single-center study, with a 6-months follow-up was performed to determine the efficacy of two different treatment modalities (surgery alone versus surgery plus compression) in the treatment of VLU in patients with primary venous insufficiency. Patients with secondary venous insufficiency and/or thrombosis were excluded from the study. Overall, 71 patients were randomized (37 men, 34 women; mean age 60 years) into two groups: the group A ? 34 patients who underwent surgical intervention (stripping) and postoperatively were treated with simple wound dressing only, and the group B ? 37 patients who underwent surgical intervention (stripping) and wore a heelless open-toed elastic class III compression device knitted in tubular form ?Tubulcus? (Laboratoires Innothera, Arcueil, France). All patients in group B were instructed to wear compression device continuously during the day and night. The study was performed at the Clinic for Cardiovascular and Transplant Surgery, Clinical Centre Nis (Serbia) with primary endpoint of the study being complete ulcer healing at 180 days. Results. The healing rate was 29.41% (10/34) in the group A, and 56.76% (21/37) in the group B (p &lt; 0.01). Mean healing time in the group A was 141 ?15 days, and in the group B it was 98 ?12 days (Log-rank life table analysis: p &lt; 0.001). Conclusion. This study suggests that for VLU in patients with primary venous insufficiency, surgery plus compression therapy provides higher healing rate and faster healing time compared to surgery only.

Assessment of the use of Unna boot in the treatment of chronic venous leg ulcers in adults: systematic review protocol

IntroductionChronic venous insufficiency (CVI) is an anomaly of the normal functioning of the venous system caused by valvular incompetence with or without the obstruction of venous flow. This condition can...

Effectiveness of two bundles in venous leg ulcer healing: A randomized controlled trial

The objective of this study was to compare the effectiveness of 2 bundles in venous leg ulcer healing. This study is a open, randomized, controlled clinical trial with parallel treatment, 1:1 allocation rate, and 24-week follow-up. Twenty-eight patients with venous leg ulcers of the lower limbs were allocated to 2 groups: group A (n=14) and group B (n=14). The mean age of the participants was 59.67±11.95years, and the mean ulcer surface area was 29.32 (±98.43) cm2. The primary outcome was ulcer healing. Secondary outcomes were wound area reduction rate, Pressure Ulcer Scale of Healing (PUSH) scores, and the presence and intensity of pain before, during and after dressing change. Two different bundles were applied in 2 phases to the randomized groups. All participants engaged in an educational activity, performed exercises, rested with legs elevated, received oral nutrition supplementation (Cubitan; Danone Nutricia), and had their ulcers cleaned with warm saline solution and biguanide polyhexanide solution (Prontosan; B. Braun). Topical therapy in the first phase was papain 2% or 4% for group A and 2% hydrogel for group B. Both groups received single-layer elastic compression therapy (SurePress; ConvaTec). In the second phase, group A received compression therapy with Unna boot (Viscopaste; Smith-Nephew) as the primary dressing, while group B received a cellulose membrane (Membracel; Vuelo Pharma) followed by the Unna boot (Viscopaste; Smith-Nephew).In group A, 71.42% of the ulcers healed; in group B, the figure was 64.28%. Wound area, PUSH scores, and the occurrence and intensity of pain decreased significantly and equivalently in groups A and B.Both bundles are effective in the treatment of venous leg ulcers and pain relief.