Randomised, Double Blind, Multicentre, Placebo Controlled Study of Sulodexide in the Treatment of Venous Leg Ulcers

2002 ◽  
Vol 87 (06) ◽  
pp. 947-952 ◽  
Author(s):  
Gaetano Scondotto ◽  
Giancarlo Agnelli ◽  
Daniele Aloisi ◽  
Ernesto Palazzini ◽  
Villiam Zamboni ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Time Course ◽  
Local Treatment ◽  
Additional Patient ◽  
Study Endpoint ◽  
Controlled Study ◽  
Primary Study ◽  
Number Needed To Treat ◽  
Leg Ulcers ◽  
Venous Leg Ulcers

SummarySulodexide, a highly purified glycosaminoglycan, was investigated for treatment of venous leg ulcers. Patients (n = 235) undergoing local treatment including wound care and compression bandaging, were randomised to receive either sulodexide or matching placebo for three months. Primary study endpoint was complete ulcer healing after 2 months; secondary endpoints were ulcer healing at 3 months and the time-course changes of ulcer areas.The proportion of patients with complete ulcer healing was higher with sulodexide at 2 months (p = 0.018) and 3 months. The “number needed to treat” to obtain one additional patient healed with sulodexide was 7 at 2 months and 5 at 3 months. The changes in ulcer surface area with time were significant for sulodexide only (p = 0.004). Fibrinogen significantly decreased in sulodexide patients (p = 0.006).In conclusion, sulodexide associated with local treatment proved to be effective and well tolerated in the management of venous leg ulcers.

Venous Leg Ulcer Healing: A Randomized Prospective Study of Long-Stretch versus Short-Stretch Compression Bandages

1998 ◽  
Vol 13 (2) ◽  
pp. 59-63 ◽  
Author(s):  
L. Danielsen ◽  
S. M. Madsen ◽  
L. Henriksen
Keyword(s):  
Ulcer Healing ◽  
Venous Ulcer ◽  
Positive Influence ◽  
Compression Bandage ◽  
Leg Ulcers ◽  
Venous Leg Ulcer ◽  
Venous Leg Ulcers ◽  
Area Reduction ◽  
Compression Bandages ◽  
Table Analysis

Objective: To compare the efficacy of a long-stretch bandage with that of a short-stretch compression bandage. Design: Prospective evaluation of healing of venous leg ulcers in blindly randomized groups of patients. Setting: Bispebjerg Hospital, Copenhagen, Denmark. Patients: Forty-three patients with venous leg ulcers were included. Forty legs in 40 patients were evaluated at 1 month (34 patients), 6 months (32 patients) or 12 months (27 patients). Interventions: Both types of bandage were used at a width of 10 cm and applied using the same spiral bandaging technique. Main outcome measures: Ulcer healing and ulcer area reduction. Results: Healed ulcers after 1 month were observed in 27% of the long-stretch group and in 5% of the short-stretch group ( p = 0.15); after 6 months the corresponding figures were 50% and 36% ( p = 0.49) and after 12 months 71% and 30% ( p = 0.06). Using life-table analysis the predicted healing rate in the long-stretch group after 12 months was 81% and for the short-stretch group 31% ( p = 0.03). The mean of relative ulcer areas at 1 month was 0.45 for the long-stretch group and 0.72 for the short-stretch group ( p = 0.07), at 6 months the corresponding figures were 0.81 and 0.60 ( p = 0.25) and at 12 months 0.25 and 0.95 ( p = 0.01). Conclusions: The present study appears to indicate a Positive influence of the elasticity of a compression bandage on venous ulcer healing.

Bevacizumab biosimilar and reference bevacizumab in subjects with stage IIIB/IV no squamous non-small cell lung cancer (NSCLC) (STELLA study): Results for the primary endpoint in a confirmatory, double-blind, randomized, controlled study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21542-e21542
Author(s):  
Susana Millan ◽  
Dmytro Trukhin ◽  
Oleksii Kolesnik ◽  
Elena Poddubskaya ◽  
Andric Zoran ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Objective Response ◽  
Stage Iiib ◽  
Study Endpoint ◽  
Controlled Study ◽  
Primary Study ◽  
Double Blind ◽  
Study Results ◽  
Significant Difference ◽  
Secondary Endpoints

e21542 Background: MB02 is a proposed biosimilar of the reference bevacizumab. A multinational, double-blind, randomized, parallel group clinical study (STELLA) is undergoing to confirm clinical similarity between MB02 and bevacizumab in patients with stage IIIB/IV no squamous NSCLC. Methods: Subjects were randomized 1:1 to MB02 or bevacizumab (15 mg/kg) plus chemotherapy (paclitaxel [P] 200 mg/m2 and carboplatin [C] AUC6) on Day 1 of every 3-week cycle for 6 cycles (Week 18) followed by MB02/bevacizumab in blinded monotherapy until disease progression, treatment intolerance, death, patient withdrawal or end of study (Week 52). As primary study endpoint, the efficacy by means of the objective response rate (ORR) evaluated by an independent radiological committee (IRC) was compared between arms at Week 18. Secondary endpoints were Progression Free Survival (PFS) and Overall Survival (OS), safety and immunogenicity (assessed at 18 and 52 weeks). Results: 627 patients were randomized: MB02 (n = 315) and bevacizumab (n = 312). Demographic and baseline characteristics were well balanced between arms. The ORR results were comparable for subjects receiving MB02 or bevacizumab plus P/C. A Risk Ratio (RR) of 1.013 (90% CI: -0.037% to 0.059) and a Risk Difference (RD) of 0.011 (90% CI: -0.037% to 0.059), were within the similarity margin predefined by FDA (0.73, 1.36) and EMA (-12%, +12%) respectively. This ORR assessed by IRC was consistent with the investigator assessment criteria. There was no significant difference between arms for secondary efficacy endpoints (PFS/OS) at week 18. Up to primary endpoint cut-off point, the safety assessment showed no significant differences between MB02 and bevacizumab arms (including the immunogenicity assessment) in terms of nature, frequency and severity of the adverse events (AE), being anaemia and hypertension the most common IMP-related AEs, with a RD between treatment groups < 5%. New signals or observable trends were no reported for MB02-treated subjects. Additional information on the secondary endpoints will be available at week 52 (end of monotherapy period). Conclusions: The statistical analysis executed for ORRs confirm the equivalence of MB02 and bevacizumab, supporting the clinical activity of MB02 treatment. MB02 was well tolerated with manageable AEs in patients with Stage IIIB/IV NSCLC. Clinical trial information: NCT03296163.

Cyclandelate in the Prophylaxis of Migraine: A Placebo-Controlled Study

Cephalalgia ◽  
2001 ◽  
Vol 21 (1) ◽  
pp. 66-70 ◽  
Author(s):  
HC Diener ◽  
P Krupp ◽  
T Schmitt ◽  
G Steitz ◽  
K Milde ◽  
...  
Keyword(s):  
Baseline Period ◽  
Migraine Prophylaxis ◽  
Study Endpoint ◽  
Controlled Study ◽  
Primary Study ◽  
Parallel Group ◽  
Primary Study Endpoint ◽  
Placebo Phase ◽  
Secondary Endpoints ◽  
Autonomic Disturbances

The prophylactic action of cyclandelate was investigated in a multicentre, randomized, placebo-controlled, parallel group study. A 4-week baseline period was followed by a 4-week placebo phase and a 16-week treatment period with either 1600 mg cyclandelate or placebo. Patients ( n = 251) with two to six migraine attacks/month were randomized. Neither the primary study endpoint (reduction of migraine days from baseline to the last 28 days) nor most of the secondary endpoints (reduction in the number of migraine attacks, severity or duration of attacks, frequency of autonomic disturbances, medication for treatment of attacks) showed a difference between cyclandelate and placebo. Cyclandelate, however, was superior to placebo in a global impression of efficacy rated by the patients and the treating physicians. Both treatments were well tolerated. In conclusion, cyclandelate was not superior to placebo in the prophylaxis of migraine with regard to parameters usually used in migraine prophylaxis trials.

Healing rates following venous surgery for chronic venous leg ulcers in an independent specialist vein unit

2013 ◽  
Vol 28 (3) ◽  
pp. 132-139 ◽  
Author(s):  
C A Thomas ◽  
J M Holdstock ◽  
C C Harrison ◽  
B A Price ◽  
M S Whiteley
Keyword(s):  
Retrospective Study ◽  
Clinical Improvement ◽  
Ulcer Healing ◽  
Surgical Intervention ◽  
Response Rate ◽  
Significant Proportion ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Venous Surgery

Objectives This is a retrospective study over 12 years reporting the healing rates of leg ulcers at a specialist vein unit. All patients presented with active chronic venous leg ulcers (clinical, aetiological, anatomical and pathological elements [CEAP]: C6) and had previously been advised elsewhere that their ulcers were amenable to conservative measures only. Method Seventy-two patients (84 limbs) were treated between March 1999 and June 2011. Patients were contacted in August 2011 by questionnaire and telephone. Of 72 patients, two were deceased and two had moved location at follow-up, so were not contactable. Fifty patients replied and 18 did not (response rate 74%), representing a mean follow-up time of 3.1 years. Results Ulcer healing occurred in 85% (44 of 52 limbs) of which 52% (27) limbs were no longer confined to compression. Clinical improvement was achieved in 98% of limbs. Conclusions This study shows that a significant proportion of ulcers currently managed conservatively can be healed by surgical intervention.

Cetuximab with or without sorafenib in recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6047-6047 ◽  
Author(s):  
Jill Gilbert ◽  
Michael J. Schell ◽  
Xiuhua Zhao ◽  
Barbara A. Murphy ◽  
Tawee Tanvetyanon ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Single Agent ◽  
Infusion Reaction ◽  
Study Endpoint ◽  
Controlled Study ◽  
Primary Study ◽  
Clinical Activity ◽  
Patients Âgés ◽  
Significant Difference ◽  
The Mean

6047 Background: For patients with R/M SCCHN, cetuximab, a monoclonal antibody against EGFR, is approved as a single agent and has a survival benefit when combined with chemotherapy. We hypothesized that addition of sorafenib, a multi-kinase inhibitor of targets including VEGFR, to cetuximab may have greater clinical benefit than cetuximab alone. Methods: This trial was designed as a blinded, randomized phase II, placebo-controlled study of cetuximab at 400 mg/m2 IV on day 1 followed by 250 mg/m2 IV weekly plus placebo bid (Arm A) or cetuximab at the same dose and schedule plus sorafenib 400 mg po bid (Arm B), each in 21 day cycles. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility. Target sample size was 84 patients with 83% power to detect a 2-month increase in PFS, the primary study endpoint. Interim analysis was planned at midpoint, requiring hazard ratio < 1 to proceed to the second stage of study. Serum cytokine and tumor HPV ISH and p16 analyses were performed. Results: Of 56 patients (ages 26-74, 80% male) enrolled, 53 patients received treatment and 41 were evaluable for response. Of the patients who received therapy, 26 received cetuximab only (Arm A). For Arm A, the mean number of cycles delivered was 4.3 (range 1-16) and the mean for Arm B was 3.3 (range 1-11). The most common grade 3/4 AEs were fatigue (2 A, 1 B), hypertension (3 B), infusion reaction (both arms), and diarrhea (2 B). Arm A had 2 PRs and Arm B had 4 PRs. Median OS was 7 mo and 5.9 mo respectively. Median PFS was 3.1 mo for both arms. 24 patients had pre-treatment cytokine measurements. Of the 12 measured cytokines, high TGFB1 level was significantly correlated with inferior PFS (4.6 mo vs 1.6 mo), regardless of arm (p=0.015). 38 patients had tumors available for p16 staining (31 neg and 7 pos). 3 of 7 p16 pos were also HPV ISH pos. The p16 neg patients had significantly improved PFS (3.5 mo vs 1.6 mo) regardless of arm (p=0.032) but no difference in OS (p=1.0). Conclusions: Both arms demonstrated clinical activity although no significant difference was observed. However, a subset of patients with p16 neg tumors or low serum TGFB1 may have a greater benefit with cetuximab-based therapy. Clinical trial information: NCI-2012-02847.

Cost-effectiveness of using intermittent pneumatic compression to manage hard-to-heal venous leg ulcers in the UK

2021 ◽  
Vol 30 (7) ◽  
pp. 544-552
Author(s):  
Julian F Guest ◽  
Karen Staines ◽  
Nina Murphy
Keyword(s):  
Cost Effectiveness ◽  
Standard Care ◽  
Cost Effective ◽  
Intermittent Pneumatic Compression ◽  
Quality Adjusted Life Year ◽  
Controlled Study ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Cost Effective Treatment ◽  
The Cost

Objective: To estimate whether thigh-administered intermittent pneumatic compression (IPC) could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of hard-to-heal venous leg ulcers (VLUs). Method: A Markov model was constructed depicting the management of hard-to-heal VLUs with IPC plus standard care or standard care alone over a period of 24 weeks. The model estimated the cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2019/20 prices. Results: Treatment of hard-to-heal VLUs with IPC plus standard care instead of standard care alone is expected to increase the probability of healing by 58% (from 0.24 to 0.38) at 24 weeks and increase health-related quality of life over 24 weeks from 0.32 to 0.34 QALYs per patient. Additionally, the cost of treating with IPC plus standard care (£3,020 per patient) instead of standard care alone (£3,037 per patient) has the potential to be cost-neutral if use of this device is stopped after 6 weeks in non-improving wounds. Sensitivity analysis showed that the relative cost-effectiveness of IPC plus standard care remains <£20,000 per QALY with plausible variations in costs and effectiveness. Conclusion: Within the limitations of this study, the addition of IPC to standard care potentially affords a cost-effective treatment to the NHS for managing hard-to-heal VLUs. However, a controlled study is required to validate the outcomes of this analysis.

Lothian and Forth Valley Leg Ulcer Healing Trial, Part 2: Knitted Viscose Dressing versus a Hydrocellular Dressing in the Treatment of Chronic Leg Ulceration

1992 ◽  
Vol 7 (4) ◽  
pp. 142-145 ◽  
Author(s):  
M. J. Callam ◽  
D. R. Harper ◽  
J. J. Dale ◽  
D. Brown ◽  
B. Gibson ◽  
...  
Keyword(s):  
Pain Relief ◽  
Ulcer Healing ◽  
Outcome Measure ◽  
Leg Ulcer ◽  
Leg Ulcers ◽  
Multilayer Systems ◽  
Venous Leg Ulcers ◽  
Patients With Diabetes ◽  
Interaction Testing ◽  
Standard Techniques

Objective: To compare a new ‘advanced’ hydrocellular Polyurethane dressing (HPD) (Allevyn) with a traditional simple non-adherent knitted viscose dressing (KDV) (Tricotex) in the treatment of chronic venous leg ulcers. Design: A randomized trial of factorial design, with interaction testing, to allow the evaluation of two different therapeutic components (dressing and bandages) within a single trial. The treatment period was 12 weeks or until healing, whichever occurred sooner. Setting: The Leg Ulcer Clinics of Edinburgh and Falkirk and District Royal Infirmaries, Scotland. Patients: 132 patients with chronic venous leg ulcers were randomized, 66 to HPD and 66 to KVD. Principal exclusions were patients with diabetes, rheumatoid disease or Doppler ankle/brachial pressure indices of less than 0.8. There were 28 withdrawals (15 KVD, 13 HPD). These were considered as treatment failures. Interventions: Dressings and bandaging were applied by specialist leg ulcer nurses using standard techniques throughout, the bandaging being randomized to either elastic or non-elastic multilayer systems. Main outcome measure: The principal end-point was ulcer healing. Also monitored were healing rates, pain and the frequency of dressing changes. Results: Pain relief was significantly better in the HPD group ( p=0.01). Thirty-one (47%) of the HPD patients healed within 12 weeks compared with only 23 (35%) of the those treated with KVD (95% confidence limits for difference, −5% to +29%). The higest healing rates (61% for all ulcers and 74% for those less than 10 cm2) were observed in the subgroup in which HPD was used in combination with an elastic bandaging system. Conclusion: Patients treated with HPD did significantly better in terms of pain relief, although the higher healing rates observed in this group failed to reach significance at the 5% level.

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