Low-power HeNe laser treatment of venous leg ulcers.

Clinical observations have suggested that low-energy lasers, mainly helium-neon (HeNe) lasers, might stimulate wound healing. A controlled study of the effects of low-power HeNe laser was performed in conjunction with a standard treatment for healing chronic venous leg ulcers on 46 patients divided randomly into two groups. All patients received standard treatment (paste-impregnated bandage and a self-adhesive elastic bandage) plus either HeNe laser (wave-length, 632.8 nm; beam power, 6 mW; continuous emission, energy density, 4 J/cm2) or placebo HeNe laser twice weekly for 12 weeks. The areas of healing were examined and compared percentage-wise after 2, 4, 6, 8, and 12 weeks. There were no significant differences in the proportion of healed ulcers or ulcer area in the HeNe group compared with the placebo group.     

Local therapy and treatment costs of chronic, venous leg ulcers with electrical stimulation (Dermapulse®): A prospective, placebo controlled, double blind trial

The purpose of our study was the evaluation of the therapeutic benefit and the economical profit of low-frequency pulsed current applied to therapy-resistant venous leg ulcers. We investigated 39 patients in a prospective, placebo-controlled, double blind study on the effect of low-frequency pulsed current (Dermapulse^®) on healing in chronic venous ulcers during a 4-month course of treatment. All patients had chronic venous ulcers. The following criteria were recorded: ulcer size, pain, capillary density, and transcutaneous oxygen partial pressure. In verum group 3, ulcers healed and ulcer area was reduced significantly. In placebo group two ulcers healed. Ulcer size was reduced significantly in each group (paired test), the difference of ulcer area reduction between the "verum" and the placebo group (unpaired test) was not significant. Capillary density in the ulcer increased in both groups. In verum group, electrical stimulation led to rapid and lasting reduction of pain (unpaired test, p =0.049). By means of the process calculation method for the subgroup of outpatients this treatment method was economically effective. Electrical stimulation seems to be a viable treatment option for therapy-resistant venous leg ulcers.     

NorLeu3‐A(1–7) stimulation of diabetic foot ulcer healing: Results of a randomized,parallel‐group,double‐blind,placebo‐controlled phase 2 clinical trial

This randomized, double‐blind, placebo‐controlled Phase 2 clinical trial explored NorLeu³‐A(1–7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks’ once‐daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks’ standard of care. DSC127 was assessed for safety (including laboratory values and adverse events), primary efficacy (% ulcers completely epithelialized at Week 12), and durability of effect. Baseline, demography, and safety parameters were compared between intent‐to‐treat groups and were comparable. Dose‐response curves for DSC127 effect on % area reduction from baseline at Week 12 (40% placebo; 67% 0.01% DSC127; 80% 0.03% DSC127) and 24 (23% placebo; 53% 0.01% DSC127; 95% 0.03% DSC127) followed a log‐linear pattern for both intent‐to‐treat and per‐protocol populations. Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo‐treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.     

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.     

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.     

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.     

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.     

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.     

Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective,randomised, multicentre study

This 12‐week, prospective, randomised, controlled multi‐centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix (AM) (study group) and standard of care (control group) therapies. Eighty‐six patients were randomised into study (47 patients) and control (39 patients) groups. No significant differences in demographics or pre‐treatment ulcer data were calculated. Complete healing and mean healing time were 69·6% and 5·7 weeks, respectively, for the study group and 46·2% and 6·8 weeks, respectively, for the control group. The proportion of healed ulcers between the groups was statistically significant (P = 0·0289), with odds of healing in the study group 2·7 times higher than in the control group. Kaplan–Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate (P = 0·015) for the control group (53·9%) compared with the study group (30·4%). After adjusting for ulcer size at presentation, which was a statistically significant covariate (P = 0·0194), a statistically significant difference in non healing rate between groups was calculated (P = 0·0233), with odds of healing 2·0 times higher in the study versus control group. This study supports the use of single‐application AM therapy as an effective treatment of diabetic, neuropathic ulcers.     

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.     

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.     

Effect of electrical stimulation waveform on healing of ulcers in human beings with spinal cord injury

Various electrical stimulation waveforms have been used to enhance wound healing, with little consideration for potential differences in their physiologic effect. The present study evaluated the effect of stimulation waveform and electrode placement on wound healing. Eighty patients with spinal cord injury and one or more pressure ulcers were treated. A total of 185 ulcers received 45 minutes of stimulation daily. Each ulcer was subjected to one of four treatment protocols: asymmetric biphasic waveform, symmetric biphasic waveform, microcurrent stim-ulation, or a sham control protocol. Electrodes were placed outside the wounds, over intact skin and surrounding the area of the ulcer. Data were categorized by ulcers which healed during the protocol and those which did not. Analysis of the "good response" ulcers (n = 104) showed significantly better healing rates for those receiving stimulation with the asymmetric biphasic waveform, compared with the control and microcurrent groups. Mean healing rates from the present study were similar to previously reported measures. The waveforms studied possessed minimal polar capabilities, and the electrodes were placed outside the wound. These data show that electrical stimulation clearly enhanced healing of pressure ulcers in a significant number of individuals with spinal cord injury; the physiologic implications of these findings relative to the mechanism(s) by which electrical stimulation enhances wound healing are discussed. However, extrapolation of these results to patients with other types of wounds must await further study.     

Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial

Several small studies have indicated that the systemic administration of pentoxifylline may accelerate healing of venous leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of pentoxifylline on healing. The study used a prospective, randomized, double-blind, parallel group placebo controlled design in a multicenter outpatient setting. Patients with one or more venous ulcer were enrolled, with all patients receiving standardized compression bandaging for treatment for their ulcers. Patients were also randomized to receive either pentoxifylline 400 mg, pentoxifylline 800 mg (two 400 mg tablets), or placebo tablets three times a day for up to 24 weeks. The main outcome measure was time to complete healing of all leg ulcers, using life table analysis. The study was completed as planned in 131 patients. Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to complete healing was 100, 83, and 71 days for placebo, pentoxifylline 400 mg, and pentoxifylline 800 mg three times a day, respectively. Over half of all patients were ulcer free at week 16 (placebo) and at week 12 in both pentoxifylline groups. Whereas the placebo group had only achieved complete healing in half of the cases by week 16, all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely. Treatment with pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups. Complete wound closure occurred at least 4 weeks earlier in the majority of patients treated with pentoxifylline by comparison to placebo. A higher dose of pentoxifylline (800 mg three times a day) was more effective than the lower dose. We conclude that pentoxifylline is effective in accelerating healing of leg ulcers.     

Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies

The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic, full thickness, lower extremity diabetic ulcers are presented. The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks' duration. Following initial complete sharp debridement of the ulcer, patients were randomized to receive a standardized regimen of good ulcer care alone, good ulcer care plus placebo gel, or good ulcer care plus becaplermin gel-30 microg/g, or good ulcer care plus becaplermin gel-100 microg/g, with various combinations of regimens used in the four studies. Safety was assessed by monitoring adverse events and by clinical laboratory evaluations. Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies. Based on an analysis of patients with baseline ulcer area common to all trials (相似文献   

A randomized,controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers

HYPOTHESIS: Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers. DESIGN: Randomized, prospective, controlled multicenter trial. SETTING: University teaching hospitals and primary care centers. PATIENTS: A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer. INTERVENTIONS: Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks. MAIN OUTCOME MEASURE: Complete healing of the study ulcer (wound). RESULTS: After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze. CONCLUSIONS: Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.     

The K-Four bandage system: evaluating its effectiveness on recalcitrant venous leg ulcers

This evaluation examined the effectiveness of the K-Four (Parema) high compression bandage system on 50 patients with recalcitrant 'hard-to-heal' venous leg ulcers and relates the outcome to an earlier randomised study which compared three other four-layer bandage systems. Twelve-week healing rates were 53.2% in the current series, which included patients with poor mobility, large ulcers and long pretreatment ulcer duration, rising to 69.5% at 20 weeks. When account was taken of known risk factors for delayed ulcer healing, no significant difference could be identified between between either K-Four or the earlier evaluated bandages, which included the original Charing Cross system, where the overall healing rates were 64.5% and 80%, respectively, at 12 and 20 weeks. It would seem more likely that treatment outcome is related to patient risk factors for delayed healing and bandaging expertise than to the bandage system employed.     

Randomized trial and local biological effect of autologous platelets used as adjuvant therapy for chronic venous leg ulcers

OBJECTIVES: Platelet products have been proposed as adjuvant therapy for wound healing. We undertook this study to determine the healing effect of topically applied frozen autologous platelets (FAP) on chronic venous ulcers, compared with effect of placebo, and whether use of topical FAP modifies local expression of vascular endothelial growth factor (VEGF), keratinocyte growth factor (KGF), interleukin 8 (IL-8), and tissue inhibitor of metalloproteinase-1 (TIMP-1) in wound fluid. METHODS: This randomized, placebo-controlled, double-blind trial was carried out in institutional practice, with ambulatory patients with proved chronic venous leg ulcers. In all patients, whole venous blood was drawn for preparation of FAP. FAP or normal saline solution was applied three times per week for up to 12 weeks, together with hydrocolloids and standardized compression bandages. Leg ulcer surface was assessed with numerical pictures. IL-8, VEGF, KGF, and TIMP-1 levels were determined (enzyme-linked immunosorbent assay) in wound fluid after each 4 weeks of treatment. RESULTS: Fifteen patients were randomized into two groups with comparable leg ulcer characteristics. Mean percent reduction in ulcer area was 26.2% in the FAP group versus 15.2% in the placebo group (P =.94). One ulcer in each group was completely healed at study end. Levels of TIMP-1 increased significantly during FAP treatment. IL-8 concentration was significantly lower in wound fluid of healing ulcers than in the fluid of nonhealing ulcers, in both FAP and placebo groups. Growth factor levels were not modified with FAP treatment. CONCLUSION: Topical autologous platelets have no significant adjuvant effect on healing of chronic venous leg ulcers and increased wound fluid TIMP-1 concentration. Ulcer healing is associated with a decrease in wound fluid IL-8.     

Effect of noncontact normothermic wound therapy on the healing of neuropathic (diabetic) foot ulcers: An interim analysis of 20 patients

This is the interim analysis of a prospective, randomized, controlled study comparing diabetic foot ulcer healing in patients being treated with either noncontact normothermic wound therapy (Warm-UP; Augustine Medical Inc. Eden Prairie, MN) applied for 1 hour 3 times daily until healing or 12 weeks, or standard care (saline-moistened gauze applied once a day). Surgical debridement and adequate foot off-loading was provided to both groups. Evaluations were performed weekly and consisted of acetate tracings, wound assessment, and serial photography. Twenty patients have completed the trial and both treatment groups were distributed evenly (N = 10). Ulcers treated with noncontact normothermic wound therapy had a greater mean percent wound closure than control-treated ulcers at each evaluation point (weeks 1-12). After 12 weeks, 70% of the wounds treated with noncontact normothermic wound therapy were healed compared with 40% for the control group. In this subset of patients there have been no adverse events associated with noncontact normothermic wound therapy.     

Comparison of famotidine 40 mg with ranitidine 300 mg at night in short-term duodenal ulcer healing. A South African multicentre study

One hundred and thirty-two patients with endoscopically confirmed duodenal ulcers were entered into a 4-6-week double-blind trial of famotidine (Fm) and ranitidine (Rn). Seventy patients were randomised to Fm 40 mg at night and Rn placebo and 62 to Rn 300 mg at night and Fm placebo. Gelusil tablets were allowed for ulcer pain, and diary cards were issued. Clinical evaluations were carried out on entry and at 2 and 4 weeks, and endoscopy was repeated at 4 weeks. Patients with an unhealed ulcer at 4 weeks were continued on the same treatment for another 2 weeks and further endoscopy was carried out at 6 weeks. The groups were comparable with respect to age, sex, duration of the most recent attack, initial ulcer size and smoking, but the duration of disease tended to be longer in the Rn-treated group (P less than 0.05). Of the patients available for analysis, 75% of the Fm-treated and 78% of the Rn-treated patients were healed at 4 weeks and 91% of patients in both treatment groups were healed at 6 weeks. Gelusil consumption and symptomatic responses were comparable in the two groups, and no side-effects were noted apart from mild dizziness in 1 patient after a single Fm tablet. The mean initial size of ulcers healed at 4 weeks was significantly less than that of ulcers which were unhealed at 4 weeks (P less than 0.01), and the healing rate among smokers was significantly lower than that among non-smokers--48 of 72 patients (67%) and 41 of 45 (91%) respectively (P less than 0.01). The study shows that Fm 40 mg at night is as effective as Rn 300 mg in duodenal ulcer healing.     

Effects of low level laser therapy on the prognosis of split-thickness skin graft in type 3 burn of diabetic patients: a case series

Significant populations in burn centers are diabetic burn patients. Healing process in these patients is more difficult due to diabetes complications. The gold standard treatment for patients with grade 3 burn ulcer is split-thickness skin grafting (STSG), but in the diabetic patients, the rate of graft failure and amputation is high due to impaired tissue perfusion. The technique of low level laser therapy (LLLT) improves tissue perfusion and fibroblast proliferation, increases collagen synthesis, and accelerates wound healing. The purpose of this case report is introducing a new therapeutic method for accelerating healing with better prognosis in these patients. The protocols and informed consent were reviewed according to the Medical Ethics, Board of Shahid Beheshti Medical Sciences (IR.SBMU.RAM.REC.13940.363). Diabetic type 2 patients with 13 grade 3 burn ulcers, candidate for amputation, were enrolled in the study. We used a 650-nm red laser light, 2 J/Cm for the bed of the ulcer and an 810-nm infrared laser light 6 J/Cm² for the margins along with intravenous laser therapy with a 660-nm red light, before and after STSG for treating grade 3 burn ulcers in 13 diabetic ulcers. The results of this study showed complete healing in the last 8 weeks for all patients who were candidates for amputation. In this case series, we present 13 cases of diabetic ulcer with type 3 burn wound, candidate for amputation, who healed completely using LLLT and STSG. This is the first time that these two techniques are combined for treatment of burn ulcer in diabetic patients. Using LLLT with STSG might be a promising treatment for burn victims especially diabetic patients.