A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers.

This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB.     

The DEPA scoring system and its correlation with the healing rate of diabetic foot ulcers

The purpose of this study was to examine the validity of a new scoring system in predicting the outcome of diabetic foot ulcers. The scoring system (DEPA score) includes the depth of the ulcer (D), the extent of bacterial colonization (E), the phase of ulcer healing (P) and the associated underlying etiology (A). The scoring system was validated against the clinical outcome in terms of healing and lower-limb amputations. Eighty-four patients were included in the study: 32 patients had a DEPA score of < or =6, 34 patients had a DEPA score of 7 to 9, and 18 patients had a DEPA score of > or =10. Using the Spearman nonparametric correlation test, DEPA scoring system was accurate in predicting the outcome of management (correlation coefficient, 0.78; 95% confidence interval, 0.68 to 0.86; P <.0001) at a mean follow-up of 20 weeks. The correlation was further validated by using a linear regression model (r = 0.85; slope best-fit value, 0.51; 95% confidence interval, 0.41 to 0.59; P <.0001). All patients with DEPA scores < or =6 had excellent healing, whereas only 15% of those with a score of > or =10 had complete healing in <20 weeks. In conclusion, an increasing DEPA score is associated with increased risk of amputation and poor healing. Furthermore, inclusion of the phase of ulcer healing into the DEPA system increases the accuracy of predicting the outcome of diabetic foot ulcers.     

The effectiveness of a four‐layer compression bandage system in comparison with Class 3 compression hosiery on healing and quality of life in patients with venous leg ulcers: a randomised controlled trial

An increasing number of compression systems available for treatment of venous leg ulcers and limited evidence on the relative effectiveness of these systems are available. The purpose of this study was to conduct a randomised controlled trial to compare the effectiveness of a four‐layer compression bandage system and Class 3 compression hosiery on healing and quality of life (QL) in patients with venous leg ulcers. Data were collected from 103 participants on demographics, health, ulcer status, treatments, pain, depression and QL for 24 weeks. After 24 weeks, 86% of the four‐layer bandage group and 77% of the hosiery group were healed (P = 0·24). Median time to healing for the bandage group was 10 weeks, in comparison with 14 weeks for the hosiery group (P = 0·018). The Cox proportional hazards regression found participants in the four‐layer system were 2·1 times (95% CI 1·2–3·5) more likely to heal than those in hosiery, while longer ulcer duration, larger ulcer area and higher depression scores significantly delayed healing. No differences between groups were found in QL or pain measures. Findings indicate that these systems were equally effective in healing patients by 24 weeks; however, a four‐layer system may produce a more rapid response.     

Use of homologous platelet factors in achieving total healing of recalcitrant skin ulcers

We used homologous platelet-derived wound healing factors (HPDWHF) to achieve complete healing of recalcitrant ulcers of diverse cause. Twenty-three patients with 27 skin ulcers who had been receiving conventional wound care with no evidence of healing for an average period of 25 weeks (range, 12 to 156 weeks) were studied. The patients were first subjected to controlled wound care for 3 months, with saline solution and silver sulfadiazine dressings used in all cases. At the end of this period, persistent nonhealing ulcers were treated by topical use of HPDWHF and silver sulfadiazine. Ulcer parameters were recorded on the first day and every week during therapy until complete epithelization was achieved in either group. Each ulcer acted as its own control. In the controlled wound care group, only three ulcers in three patients achieved complete healing; the remaining 24 ulcers in 20 patients failed to achieve even 50% healing in the stipulated 3-month period. However, when subjected to HPDWHF applications, these ulcers healed completely, 100% healing occurring in 9.67 +/- 4.9 weeks (range, 3 to 19 weeks), which is highly significant (p less than 0.01). The healing response to HPDWHF applications was of uniform progression over the weeks. Only the basic cause of the ulcer determined the healing rates in this group. The shortest and the longest time to achieve 100% healing occurred in patients with diabetes (6.88 +/- 2.97 weeks) and in the venous stasis group (14.00 +/- 7.07 weeks). Age, sex, location of ulcer, ulcer duration, and ulcer measurements had no influence on the HPDWHF-stimulated healing rates. This is the earliest report of HPDWHF-stimulated repair in chronic nonhealing skin ulcers.     

Analysis of therapy-resistant venous leg ulcers

Chronic leg ulcers represent a major health-care problem with considerable socioeconomic impact. Patients with seemingly therapy-resistant leg ulcers are common to all clinics. The purpose of the present study was to (1) examine a group of patients with nonhealing venous leg ulcers treated with a double-layer bandage and (2) evaluate whether the addition of an interactive hydrocolloid wound dressing could initiate healing in these patients. Twenty-two patients with ulcers caused by venous insufficiency were included. The patients had a mean ulcer duration of 27.6 years. Duration of the present ulcer was at least 1 year (mean >/= 4.1 years). Twenty of the 22 patients showed massive lipodermatosclerosis. Before inclusion, all patients had used double-layer bandage consisting of a zinc-impregnated bandage or stocking and a self-adhesive compression bandage for 1 year or longer without improvement. The new regimen was a triple-layer treatment with the hydrocolloid water applied over the ulcer and the traditional double-layer bandage unchanged. Three patients were dropped from the study. Nineteen patients were followed until healing or for 10 months. Nine of the 19 patients who completed the study healed. Ulcer area was reduced by 70% or greater in 7 patients and by 30% to 40% in two patients. One ulcer did not respond to the treatment and worsened slightly. The results of this study were encouraging and indicate that the triple-layer treatment with the hydrocolloid dressing applied to the ulcer should be evaluated in a randomized, controlled study in patients with less pessimistic prognoses.     

Randomized clinical trial of three-layer paste and four-layer bandages for venous leg ulcers: Meyer FJ,McGuinness CL,Lagattolla NRF,et al. Br J Surg 2003;90:934-40

ConclusionThree-layer compressive bandages are slightly more effective than four-layer compressive bandages for healing venous leg ulcers.SummaryOne hundred thirty-three patients with venous ulcers treated in a single clinic were stratified according to ulcer size and then randomized to receive three-layer or four-layer bandages. Ulcers were stratified by calculating the maximum length and breadth of the ulcer and multiplying these values. Ulcers were grouped into small (>0.25–<2.5 cm²), medium (2.5-25 cm² ), and large (25-100 cm² ) groups. Ulcers smaller than 0.25 cm² or larger than 100 cm² were excluded. Patients were excluded if they had diabetes, connective tissue disorders, rheumatoid arthritis, or human immunodeficiency virus, or were positive for sickle cell disease.Three-layer bandages consisted of a hypoallergenic paste, followed by a compression bandage, followed by Tubigrip. Four-layer bandages were comprised of orthopedic wool, a crepe bandage followed by a compressive bandage, and finally a Coban bandage. Patients were followed up for 1 year. Time to complete healing, defined as “restoration of entirely unbroken skin integrity without any purulent discharge after removal of all scabs,” was the primary end point.Complete ulcer healing occurred in 80% of patients treated with three-layer bandages and 65% of patients treated with the four-layer bandaging technique (P = .031). The median time to complete healing was 12 and 16 weeks, respectively (P = .04). The difference in healing did not become apparent until after 20 weeks of treatment. Large venous ulcers were less likely to heal. The adverse effect of ulcer size on healing was apparent in both the three-layer and four-layer bandage groups. Previous venous thrombosis or popliteal reflux did not affect ulcer healing.CommentBoth four-layer and three-layer bandaging techniques are effective in management of venous leg ulcers, with three-layer bandages apparently slightly more efficacious. Neither technique is suitable for all patients. In some patients allergy will develop to the paste component of the three-layer bandage, and other patients find the four-layer bandage bulky and uncomfortable. Not all forms of compression therapy are suitable for all patients. Physician and patient willingness to explore alternative management techniques is crucial to success of conservative therapy of venous ulcers.     

Electrical nerve stimulation improves healing of diabetic ulcers.

A controlled study of the effects of electrical nerve stimulation (ENS) was performed in conjunction with a standard treatment for healing chronic diabetic ulcers on 64 patients divided randomly into two groups. All patients received standard treatment (paste-impregnated bandage and a self-adhesive elastic bandage) plus placebo ENS or ENS (alternating constant current; frequency, 80 Hz; pulse width, 1 msec; intensity-evoking strong paresthesias) for 20 minutes twice daily for 12 weeks. Comparison of percentages of healed ulcer area and the number of healed ulcers was made after 2, 4, 6, 8, and 12 weeks. There were significant differences (p < 0.05) in both ulcer area and healed ulcers in the ENS group compared with the placebo group after 12 weeks of treatment. The results of the present study support the use of ENS in diabetic ulcers. ENS is easy to apply and can be used by the patient at home following instructions from a medical doctor or a therapist experienced in electrical stimulation and the treatment of ulcers. Additional studies are needed to identify the mechanisms involved in the promotion of ulcer healing with electrical stimulation and to determine the stimulus variables that most efficaciously accelerate tissue repair.     

Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers

BACKGROUND: Many venous ulcers are healed by the application of external compression. It has been suggested that bandages capable of producing greater compression enhance healing. The aim of this study was to compare the time to total healing of venous ulcers in two groups of patients treated with different compression regimens in a randomized prospective trial. METHODS: A total of 112 patients was studied and all were treated with a zinc-impregnated paste bandage applied directly to the ulcer. Fifty-seven patients had the paste covered by Tensopress and 55 by Elastocrepe bandages. Both groups had a tubular bandage applied over the top to retain the bandage in place. All ulcers were stratified and randomized within one of three size groups. The 'venous' aetiology of the ulcer was confirmed on completion by calf pump function tests. RESULTS: By 26 weeks, 58 per cent of the patients treated with Tensopress and 62 per cent of those treated with Elastocrepe bandages were healed. The median healing times were 9 and 9.5 weeks respectively. Similar numbers of patients were excluded or withdrawn from both groups. Large ulcers healed significantly more slowly than small ulcers. CONCLUSION: There was no significant improvement in venous ulcer healing using higher compression elastic bandages.     

The Ulcerated Leg Severity Assessment score for prediction of venous leg ulcer healing

BACKGROUND: The aim of the study was to create a reliable scoring system for the prediction of venous ulcer healing in patients treated with compression. METHODS: A prospective baseline study to identify risk factors for venous ulcer healing was undertaken between March 1999 and August 2001. All patients were treated with multilayer compression. A number of variables were related to 24-week healing rates. A Cox regression model was used to identify risk factors that predicted ulcer healing, from which a scoring system was developed and validated prospectively between February 2004 and March 2005. RESULTS: In the baseline study of 229 patients, patient age, ulcer chronicity and venous refill time (VRT) of 20 s or less were identified as risk factors. Using these factors and hazard ratios from the Cox regression analysis, the following formula was devised: Ulcerated Leg Severity Assessment (ULSA) score=age+chronicity-50 (when VRT is greater than 20 s). Patients with an ULSA score of 50 or less had higher 24-week ulcer healing rates than those with higher scores in both the baseline study (P<0.001, log rank test) and the validation study performed in 86 patients (P=0.007, log rank test). CONCLUSION: The ULSA score may help to identify patients with venous ulcers unlikely to respond to conventional treatment who could be offered alternative therapy.     

Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I)

BACKGROUND: A randomized clinical trial was undertaken to determine the relative effectiveness of four-layer and short-stretch bandaging for venous ulceration. METHODS: A total of 387 adults with a venous ulcer, who were receiving leg ulcer treatment either in primary care or as a hospital outpatient, were recruited to this parallel-group open study and randomized to either four-layer or short-stretch bandages. Follow-up continued until the patient's reference leg was ulcer free or for a minimum of 12 months. The primary endpoint was time to complete healing of all ulcers on the reference leg. Secondary outcomes included proportion of ulcers healed, health-related quality of life, withdrawals and adverse events. Analysis was by intention to treat. RESULTS: Unadjusted analysis identified no statistically significant difference in median time to healing: 92 days for four-layer and 126 days for short-stretch bandages. However, when prognostic factors were included in a Cox proportional hazards regression model, ulcers treated with the short-stretch bandage had a lower probability of healing than those treated with the four-layer bandage: hazard ratio 0.72 (95 per cent confidence interval 0.57 to 0.91). More adverse events and withdrawals were reported with the short-stretch bandage. CONCLUSION: Venous leg ulcers treated using a four-layer bandage healed more quickly than those treated with a short-stretch bandage.     

Comparison of the healing rates and complications of three four-layer bandage regimens

This randomised controlled study compares the healing rates, complications and patient and staff acceptability of three four-layer bandage regimens for leg ulcers. A total of 149 patients were recruited into the study, of whom 50 received the original Charing Cross system (CX4L), 50 a modified Charing Cross system (Parema) and 49 a commercially available kit, Robinson Ultra Four (Robinson). No significant difference was found in the healing rates of the three systems. Overall 12 weeks' healing was 65%, while the 20-week healing rates for the individual systems were 87% (CX4L), 84% (Parema) and 83% (Robinson). Analysis of known risk factors for delayed healing showed that no bandaging system had an advantage over the others. Staff familiarity resulted in an initial preference for the CX4L but there was no bandage preference by the end of the study. The data suggest that none of the systems has an advantage over the others and that cost savings can be made by pursuing a competitive pricing policy.     

Two-step autologous grafting using HYAFF scaffolds in treating difficult diabetic foot ulcers: results of a multicenter, randomized controlled clinical trial with long-term follow-up

This study evaluated the efficacy and tolerability of an autologous tissue-engineered graft--a 2-step HYAFF autograft--in the treatment of diabetic foot ulcers compared with standard care. In all, 180 patients with dorsal or plantar diabetic foot ulcers (unhealed for ≥1 month) were randomized to receive Hyalograft-3D autograft first and then Laserskin autograft after 2 weeks (n = 90; treatment group) or nonadherent paraffin gauze (n = 90; control group). Efficacy and adverse events were assessed weekly for 12 weeks, at 20 weeks, and at 18 months. The primary efficacy outcome was complete ulcer healing at 12 weeks. Wound debridement, adequate pressure relief, and infection control were provided to both groups. At 12 weeks, complete ulcer healing was similar in both groups (24% of treated vs 21% controls). A 50% reduction in ulcer area was achieved significantly faster in the treatment group (mean 40 vs 50 days; P = .018). Weekly percentage ulcer reduction was consistently higher in the treatment group. At 20 weeks, ulcer healing was achieved in 50% of the treated group as compared with 43% of controls. Dorsal ulcers had a 2.17-fold better chance of wound healing per unit time following autograft treatment (P = .047). In a subgroup with hard-to-heal ulcers, there was a 3.65-fold better chance of wound healing following autograft treatment of dorsal ulcers (P = .035). Adverse events were similar in both groups. The study results demonstrated the potential of this bioengineered substitutes to manage hard-to-heal dorsal foot ulcers.     

Risk factors for delayed healing and recurrence of chronic venous leg ulcers--an analysis of 1324 legs.

OBJECTIVE: Despite similar disease patterns and treatment, there is great variation in clinical outcome between venous ulcer patients. The aim of this study was to identify independent risk factors for venous ulcer healing and recurrence. METHODS: Consecutive patients assessed by a specialist nurse-led leg ulcer service between January 1998 and July 2003 with an ABPI>0.85 were included in this study. Independent risk factors for healing and recurrence were identified from routinely assessed variables using a Cox regression proportional hazards model. RESULTS: A total of 1324 legs in 1186 patients were studied. The 24-week healing rate was 76% and 1 year recurrence rate was 17% (Kaplan-Meier life table analysis). Patient age (p <0.001, HR per year 0.989, 95% CI 0.984-0.995) and ulcer chronicity (p =0.019, HR per month 0.996, 95% CI 0.993-0.999) were independent risk factors for delayed ulcer healing. Ulcer healing time (p <0.001, HR per week 1.016, 95% CI 1.007-1.026) and superficial venous reflux not treated with surgery (p =0.015, HR 2.218, 95% CI 1.166-4.218) were independent risk factors for ulcer recurrence. CONCLUSIONS: Elderly patients with longstanding ulcers should be targeted for further research and may benefit from adjunctive treatments to improve clinical outcomes. Patients not treated with superficial venous surgery were at increased risk of leg ulcer recurrence.     

Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency.

OBJECTIVE: Although newer techniques to promote the healing of leg ulcers associated with chronic venous insufficiency are promising, improved healing rates and cost effectiveness are unproven. We prospectively followed a series of patients who underwent treatment with outpatient compression for venous stasis ulcers without adjuvant techniques to determine healing rates and costs of treatment. METHODS: Two hundred fifty-two patients with clinical or duplex scan evidence of chronic venous insufficiency and active leg ulcers underwent treatment with ambulatory compression techniques. The patients were prospectively followed with wound measurements at 1-week to 2-week intervals, and the factors that were associated with delayed healing were determined. RESULTS: Of all the ulcers, 57% were healed at 10 weeks of treatment and 75% were healed at 16 weeks. Ultimately, 96% of the ulcers healed, and only 1 major amputation was necessitated (0.4%). Initial ulcer size and moderate arterial insufficiency (ankle brachial index, 0.5 to 0.8; n = 34) were factors that were independently associated with delayed healing (P <.01). Patient age, ulcer duration before treatment, and morbid obesity did not significantly affect healing times. The cost of 10 weeks of outpatient treatment with compression techniques ranged from $1444 to $2711. CONCLUSION: The treatment of venous stasis ulcers with compression techniques results in reliable, cost-effective healing in most patients. Current adjuvant techniques may prove to be useful but are likely to be cost effective only in a minority of cases, particularly in patients with large initial ulcer size or arterial insufficiency.     

Refractory Venous Leg Ulcers: A Study of Risk Factors

BACKGROUND: Although certain risk factors for poor healing of leg ulcers have been identified, data concerning the characteristics of refractory ulcers have not been specifically studied in the literature. OBJECTIVE: To study the characteristics of refractory venous leg ulcers. METHODS: We retrospectively studied prognostic factors for healing in patients with refractory venous leg ulcers followed and treated in our dermatology department between January 1993 and January 2000. Each patient included in this study was compared with two patients matched for age and gender and presenting leg ulcers with normal healing, followed during the same period. RESULTS: Thirty-two of 571 patients with leg ulcers were included. The study population consisted of 20 females and 12 males with a mean age 73.5 years. The control population comprised 64 patients, 40 females and 24 males, with a mean age of 73 years. Univariate analysis demonstrated the negative prognostic impact of several previously identified factors (including surface area and history of the ulcer). In particular, multivariate analysis identified four main risk factors for refractory ulcer that are often associated in these patients: associated arterial disease, presence of post-thrombotic popliteal sequelae, recurrence of the ulcer, and disability. CONCLUSION: Four main risk factors that are often associated were identified, indicating the multifactorial nature of these refractory ulcers.     

Wound-healing trajectories as outcome measures of venous stasis ulcer treatment

Outcome measures of venous ulcer healing are not uniformly accepted. Stringent criteria of 100% closure fail to provide information of healing over the entire span of repair. Wound-healing trajectories (plot of percentage of wound closure versus time of wound treatment) were constructed for 232 patients treated in eight clinical trials at two independent wound care/research centres. Trajectories were constructed for ulcers that totally healed (100% closure) and those that did not (<100% closure) over a 20-week period. Kaplan-Meier survival plots determined the percentage of patients achieving total healing versus time of treatment. The wound-healing trajectories were almost identical for patients achieving complete ulcer healing, as were the trajectories for patients with less than 100% closure. The trajectories for the ulcers healing completely were significantly different from those with <100% closure. Only 60% of all patients achieved 100% closure by 20 weeks. Using linear regression, it was predicted that it would take 31 weeks for all patients to achieve total healing. Total healing is an inadequate outcome measure for healing of venous stasis ulcers. Clinical trials using this measure would require excessive time periods. As wound-healing trajectories for patients treated at two centres mimic one another, shifting the wound-healing trajectory from one of impaired healing to one of a more ideal healing course may be considered a better outcome measure for determining healing of venous stasis ulcers.     

Risk factors affecting pressure ulcer healing: Impact of prescription medications

Treatment of pressure ulcers requires removing the cause as well as eliminating factors that interfere with healing. There are no reports on the effect of medications prescribed for underlying diseases on pressure ulcers. Accordingly, the aim of this study was to investigate whether medications prescribed to patients with pressure ulcers could be a factor that influences pressure ulcer healing. We retrospectively reviewed the records of patients with pressure ulcer who were admitted to Chiba University Hospital between June 2009 and June 2015. A total of 110 patients were included in this study. In univariate analysis, there were significant differences in corticosteroid use and total caloric intake. Logistic regression analysis was performed for four factors, including corticosteroid use and total caloric intake, which were significant at P < .05, plus the two factors malignancy and body mass index, which were previously reported as factors that may affect pressure ulcer healing. The results showed that corticosteroid use [odds ratio (OR) 0.205, 95% confidence interval (CI): 0.046 to 0.911, P = .037] and total caloric intake [OR 1.002, 95% CI: 1.000 to 1.003, P = .006] were significant risk factors influencing pressure ulcer healing. This study revealed that use of corticosteroids and total caloric intake could be risk factors affecting pressure ulcer healing. These findings provide useful information for the management of pressure ulcer.     

Randomized clinical trial of three‐layer tubular bandaging system for venous leg ulcers

The safety and efficacy of three‐layer (3L) tubular bandaging as a treatment for venous ulcer healing has not been evaluated despite its use in many clinical settings to treat people with venous leg ulcers. We evaluated the safety and efficacy of 3L tubular bandage compared with short‐stretch compression bandage to heal venous ulcers in a multicenter, open‐label, parallel‐group, randomized controlled trial. We randomized 45 patients with venous leg ulcers of up to 20 cm² area and an ankle brachial pressure index of >0.8 from hospital outpatient wound clinics in Victoria and Queensland, Australia. We measured time to healing and percentage reduction of wound size from baseline to week 12. Secondary outcomes were proportion of ulcers healed, self‐reported compliance of compression bandage, and health‐related quality of life, costs, recurrence rates, and adverse events. A total of 27 ulcers healed, the proportion of healed ulcers was higher for the 3L group (17/23 [74%] vs. 10/22 [46%]) (p = 0.05). Reported bandage tolerance at all treatment visits was 21 (91%) in 3L group vs. 17 (73%) (p = 0.10). There was no difference between the groups in adverse events. Costs were substantially less in 3L group.     

Randomized trial of cohesive short-stretch versus four-layer bandaging in the management of venous ulceration.

A multicenter prospective randomized clinical trial was undertaken to compare a generic four-layer bandage system with a cohesive short-stretch system (Actico, Activa Healthcare) in the management of venous leg ulceration. Both systems are designed to produce sufficient pressure to counteract venous hypertension. Patients in leg ulcer services with leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index < 0.8) and causes of ulceration other than venous disease were excluded. For patients with bilateral ulceration, the limb with the larger area of ulceration was studied. Patients were randomized to receive either type of compression bandage and simultaneously randomized to one of two foam dressings that were changed weekly unless more frequent changes were clinically required. In all, 156 patients met entry criteria and were randomized from the 12 clinical centers with median (range) ulcer size of 4.33 (0.33-123.10) cm(2). Analysis revealed that after 24 weeks a total of 111 (71%) of patients had complete ulcer closure, 32 (21%) had withdrawn from the trial, 12 (8%) remained with open ulceration, and one patient had died. Of the 74 patients randomized to the four-layer bandage, 51(69%) had ulcer closure on treatment compared with 60/82 (73%) on the cohesive short-stretch system. Intention-to-treat analysis produced a hazard ratio for healing of 1.08 (95 percent CI 0.63-1.85, p= 0.79). Withdrawal rates were similar between groups (15, 20% four-layer bandage; 17, 21% cohesive short-stretch system). Ulcer closure rates for patients treated with the cohesive short-stretch system were similar to those for patients managed by the four-layer bandage system in this trial.     

Die chirurgische Therapie des Ulcus cruris

Chronic venous disease causing leg ulceration is an important socio-economic burden in western societies due to considerable patient discomfort and disability, loss of working days and high costs for a long-term therapy. Adequate treatment of venous ulcers requires competence in Angiology plus Vascular Surgery. Therapy aims at reduction of venous hypertension and promotion of ulcer healing. Improved and durable results of treatment are shown, if vein surgery is performed in addition to conservative strategies. Ulcer healing rates after subfascial endoscopic perforator surgery (SEPS) differ between 83% and 100%. Ulcer recurrence after a median observation period between 19.5 months and 5 years is seen in 0% to 27%. Using “Shave therapy” plus vein surgery in several studies, after a period between 9.5 and 51.5 months ulcer healing rates were 77.5 to 88%. However, secondary procedures after shaving were necessary in 28% on average. Fasciectomy and valve reconstruction of insufficient deep veins may be considered for persisting ulcers. Our own recent analysis included 103 consecutively operated legs with active or recently healed venous ulcers. After SEPS procedure, which was frequently combined with superficial vein surgery, 93% of ulcers healed after a median observation period of 3 years. Recurrent ulcers developed in 8% of patients, and 85% of the operated patients remained free of ulceration. Quality of life (QOL) is improved after ulcer healing. In our own series, 72% of patients with healed ulcers improved their QOL, in contrast to 45% in the group with persistent or recurrent ulcers. Only one third of the patients without improved QOL despite ulcer healing had discomfort related to surgery and / or ulcer scars. High ulcer healing rates after vein surgery, associated high patients acceptance and improved QOL indicate, that vein surgery is clearly beneficial for the majority of patients with venous leg ulceration.