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.     

Comparison of elastic versus nonelastic compression in bilateral venous ulcers: a randomized trial

BACKGROUND: There is controversy regarding the effectiveness of elastic vs nonelastic compression in the healing of venous leg ulcers. To gain insight into this controversy, we randomly compared a four-layer elastic bandage with a nonelastic garment (CircAid) in patients with venous leg ulcers. METHODS: Twenty-four extremities of 12 patients with bilateral leg ulcers were randomized to have a four-layer elastic bandage in 1 extremity and a nonelastic compression garment CircAid in the contralateral limb. The CEAP classification in 22 extremities was C(6 S); ES; A(D6,14,15,P18); PR; 1 extremity in 2 patients was C(6 S); E(S); A(D 6,14,15,P18); PRO. There were seven men and five women. Age ranged from 45 to 82 years, with a mean of 61 years. All patients had postthrombotic leg ulcers diagnosed clinically by duplex ultrasonography (n = 8) or by phlebography (n = 4). Every 4 weeks, patients had the ulcer area measured in square centimeters by a computerized scanning method and had the limb girth measured in centimeters at the foot, ankle, and calf. The ankle-brachial index was determined in all cases. Color photographs of the ulcer areas were taken monthly to assess healing progress. All patients were compliant. Results were assessed at 12 weeks. A patient satisfaction sheet was filled out by the patient, who circled one of the following scores: 3, very satisfied; 2, moderately satisfied; and 1, not satisfied. Cox proportional hazards models or paired t tests were used for comparison. RESULTS: The 24 limbs were randomized and divided into 2 groups of 12 each. Group A received CircAid, and group B, a four-layer elastic bandage. Duplex scanning showed a pattern of reflux in 11 limbs of each group. One limb in each group had a pattern of obstruction documented by air plethysmography (n = 2). Phlebography demonstrated the anatomic site in both limbs. The initial ulcer area in group A was 48.98 +/- 14.13 cm2 and was 50.08 +/- 18.30 cm2 in group B (P = .9285). The ulcer healing rate was significantly faster in group A compared with group B (hazard ratio, 0.56; 95% confidence interval, 0.33-0.96; P = .0173). Ulcers with hemodynamic obstruction had a protracted course when compared with the contralateral limbs with reflux. There was no significant difference in girth reduction between groups A and B (hazard ratio, 2.36; 95% confidence interval, 0.30-18.52; P = .3580). The ankle-brachial index was normal (> or = 1.0) in all patients. CONCLUSIONS: In compliant patients, venous leg ulcers randomized to nonelastic compression had a significantly faster healing rate per week than ulcers treated by the conventional four-layer compression system.     

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.     

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.     

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.     

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.     

Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks

This retrospective analysis included intent-to-treat control patient data from two published, randomised, diabetic foot ulcer (DFU) trials in an effort to differentiate ulcers that are unlikely to heal by 12 weeks despite early healing progress [≥50% percent area reduction (PAR) at 4 weeks]. Predicted and actual wound area trajectories in DFUs that achieved early healing progress were analysed from weeks 5 to 12 and compared for ulcers that did and did not heal at 12 weeks. In 120 patients who achieved ≥50% PAR by week 4, 62 (52%) failed to heal by 12 weeks. Deviations from the predicted healing course were evident by 6 weeks for non healing ulcers. A 2-week delay in healing significantly lowered healing rates (P = 0·001). For DFUs with ≥50% PAR at 4 weeks, those achieving ≥90% versus <90% PAR at 8 weeks had a 2·7-fold higher healing rate at 12 weeks (P = 0·001). A PAR of <90% at 8 weeks provided a negative predictive value for DFU healing at 12 weeks of 82%. For ulcers that fail to progress or worsen from weeks 4 to 6, and those that fail to achieve 90% PAR at 8 weeks, reevaluation of the wound and its treatment is recommended.     

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.     

Erbium: Yttrium Aluminum Garnet Laser Accelerates Healing in Indolent Diabetic Foot Ulcers

The objective of the study was to evaluate the effect of the erbium:yttrium aluminum garnet (YAG) laser on diabetic foot ulcers (DFUs) that had not responded to standard care. We retrospectively evaluated 22 nonhealing DFUs that received at least 4 weeks of standard wound care, demonstrated poor healing response, and subsequently were treated with an erbium:YAG laser. We measured the percent wound area reduction (PWAR) for the 4 weeks before initiating laser therapy and the PWAR for 4 weeks after the initiation of laser therapy. Erbium:YAG laser treatment consisted of 2 components: debridement and resurfacing. The laser settings were the same for all treatments. We used the paired t test to compare pretreatment with posttreatment wound area reduction. During the 4-week period before the initiation of laser therapy, the average PWAR was –33.6%. Four weeks after initiating treatment with the erbium:YAG laser, the average PWAR was 63.4% (p = .002) and 72.7% of wounds had ≥50% PWAR. By 12 weeks, 50% of wounds had healed. Erbium:YAG laser therapy accelerated DFU healing in a cohort of patients with ulcers that had been unresponsive to standard of care therapy.     

An aseptically processed,acellular, reticular,allogenic human dermis improves healing in diabetic foot ulcers: A prospective,randomised, controlled,multicentre follow‐up trial

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended to 40 additional patients (80 in total) to validate and extend the original findings. The entire cohort of 80 patients underwent appropriate offloading and standard of care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised to receive weekly applications of HR‐ADM plus SOC or SOC alone for up to 12 weeks. The primary outcome was the proportion of wounds closed at 6 weeks. Sixty‐eight percent (27/40) in the HR‐ADM group were completely healed at 6 weeks compared with 15% (6/40) in the SOC group. The proportions of wounds healed at 12 weeks were 80% (34/40) and 30% (12/40), respectively. The mean time to heal within 12 weeks was 38 days for the HR‐ADM group and 72 days for the SOC group. There was no incidence of increased adverse or serious adverse events between groups or any graft‐related adverse events. The mean and median HR‐ADM product costs at 12 weeks were $1200 and $680, respectively. HR‐ADM is clinically superior to SOC, is cost effective relative to other comparable treatment modalities, and is an efficacious treatment for chronic non‐healing 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.     

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.     

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.     

Ranitidine in uncomplicated duodenal ulceration. A double-blind endoscopically controlled trial

Fifty patients with endoscopically proven uncomplicated duodenal ulcers were given either ranitidine 150 mg twice daily or placebo for 4 weeks in a randomized double-blind study. After 4 weeks 76% of patients on ranitidine showed healing. Fifteen (60%) were completely healed, 5 (20%) were partly healed, and 5 had active unchanged ulcers. Of the patients on placebo 6 (27%) were completely healed, 6 (27%) were partly healed, 10 had active unchanged ulcers and 3 had absconded. Grouping partly healed with active ulcers, a Z value of 2,23 was obtained in the Mantel-Haenszel test (P = 0.013 in favour of ranitidine over placebo). Of 10 patients who were partly healed or had active ulcers after being given ranitidine in the first stage of the study, 7 healed on one further course in an open study and 3 still had active ulcers after two further courses. Of 16 patients who were partly healed or had active ulcers after 4 weeks on the placebo, 3 healed on one course of ranitidine, 6 healed on two courses, 6 still had active ulcers after two courses, and 1 absconded. No side-effects were noted. Ranitidine is a safe and effective drug for the treatment of active duodenal ulceration.     

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.     

Effect of low power gallium arsenide laser on healing of venous ulcers.

The healing of venous ulcers of the leg with and without gallium arsenide laser treatment was studied in 42 patients randomly divided into two groups. One group received standard conservative treatment and gallium arsenide laser, and the other received the same standard treatment and placebo laser treatment. There were no differences in results between the two groups.     

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.     

A stable prostacyclin analogue (iloprost) in the treatment of ischaemic ulcers of the lower limb. A Scandinavian-Polish placebo controlled, randomised multicenter study.

The clinical efficacy of the prostacyclin analogue iloprost was studied during a 2 week treatment and 6 month follow-up period in 103 patients with ischaemic ulcers who were randomised to receive active treatment or placebo. Responders were defined as those patients who achieved healing of at least one third of the ulcer area during the study period. The overall responder rate was 41.3%, compared with 25% for the control group (P = 0.086). Side effects including flushing and headache, were common. The study population had a mortality of 23% during the 6 month period, the amputation rate was 43.5% for iloprost and 50% for placebo treated patients. In this severely diseased population of patients a treatment period limited to 2 weeks did not sufficiently improve ulcer healing.     

Randomized, double-blind, placebo-controlled, dose- ranging study of granulocyte-macrophage colony stimulating factor in patients with chronic venous leg ulcers

Chronic venous leg ulcers are a common ailment with no ideal treatment. Recent reports have shown granulocyte- macrophage colony stimulating factor to be of use in the healing of these chronic wounds. Therefore, we conducted a double-blind, randomized, placebo-controlled study which enrolled 60 patients with chronic venous leg ulcers, whom we treated with placebo or with 200 or 400 microg of granulocyte-macrophage colony stimulating factor by perilesional injections of the drug in four weekly treatment episodes. Observations were conducted at each treatment visit, at weeks 5, 9, 13, and six months after the inclusion in the protocol. The number of healed wounds in the placebo and the treated arms were significantly different (p = 0.05), with 4 of 21 (19%) in the first group having healed at week 13, as compared to 12 of 21 (57%) and 11 of 18 (61%), in the 200 microg and the 400 microg groups, respectively. There were only minor side-effects attributable to the treatment, and the reobservation at 6 months showed that none of the treated ulcers recurred during that period. We conclude that granulocyte-macrophage colony stimulating factor injected perilesionally may be a useful drug for the treatment of chronic venous leg ulcers.     

What is the efficacy of "soft" and "mid" lasers in therapy of tendinopathies? A double-blind study

The efficacy of "athermic" lasers (HeNe lambda = 632.8 nm and IR diode lambda = 904 nm) in the treatment of tendinopathies was investigated in a randomized double-blind study. On 10 consecutive days, 64 patients (32 therapy, 32 placebo) were treated for 15 minutes each with a switched-on or switched-off laser under otherwise identical conditions. The extent of movement in involved joints (neutral 0 method) and rating on a pain scale for resting pain, movement pain, and pressure pain before treatment, after treatment, and 2 weeks after conclusion of therapy, as well as infrared thermography, served to check therapy. After the end of therapy, a significant reduction (P = less than 0.001) of 50% was shown for resting pain as well as reductions of 30% for movement and 30% for pressure pain. This result was identical in the therapy group and in the placebo group. There was also no indication of a different result of therapy between the therapy and placebo groups with regard to the thermographic control and the extent of movement. The breakdown of the data in terms of age, sex, and duration of disease did not provide any indications of different results for placebo or therapy. It was striking that the patients who reported sensations during or after the treatment (irrespective of whether pleasant or unpleasant) had a greater reduction of pain than the patients without sensations. This laser therapy thus did not show any effect above and beyond that in the untreated group in our double-blind clinical study.