Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001213730
Ethics application status
Approved
Date submitted
1/11/2013
Date registered
5/11/2013
Date last updated
5/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Compression therapy in venous leg ulcers
Scientific title
A comparative clinical study on five types of compression therapy in patients with venous leg ulcers
Secondary ID [1] 283500 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical therapy in wound healing 290418 0
Various types of compression therapy in leg ulcers 290419 0
Condition category
Condition code
Cardiovascular 290809 290809 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 290810 290810 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to compare five types of compression therapy in venous leg ulcers (intermittent pneumatic vs. stockings vs. multi layer vs. two layer short stretch bandages vs. Unna boots). Primary study endpoints were analysis of changes of the total ulcer surface area, volume and linear dimensions inside observed groups. The secondary end points were comparisons between all groups the number of completely healed wounds (ulcer healing rates) and percentage change of ulcer surface area.

Intervention:
In total, 147 patients with unilateral venous leg ulcers were included to this study. Participants were randomly allocated to the groups: A, B, C, D and E. All participating facilities provided patients a standard regimen of drug therapy (standard regimen was carried out for 2 months to begin our experiment – application one of five compression procedures in following group), including micronized purified flavonoid fraction 450 mg diosmin, 50 mg hesperidin, 2 tablets of 500 mg once daily. Patients in group A received 12 - chamber intermittent pneumatic compression therapy. The Flowtron Hydroven 12 System device was applied to compress the cuff covers the foot, lower leg, knee and thigh. Cuff length was 109 cm (a foot for 33 cm). Cuff expanded from foot (circumference 38 cm) to thigh (circumference 71 cm). All patients were subjected to a pressure of 60 mmHg at the ankle. In the upper chamber pressure was exerted smaller and decreases with the height (40 mmHg in the chamber at the level of the groin. Ventricular filling time was 60 s, and a discharge time of 30 s. A single setting lasted 60 min during treatment, patients were lying. Finally, participants received 40 sessions, 5 times weekly (from Monday to Friday), once a day. Patients in group B were treated with special ulcer stocking system Ulcer X providing pressure 30 – 40 mmHg at the ankle. The system were put on the leg at the outpatient clinic every morning and worn whole day (about 10–12 hours); and put off on night. Patients in group C were treated with multi layer short-stretch bandaging. The pressure values were also standardized in use of Kikuhime manometer (45–50 mmHg for superficial reflux and 50–55 mmHg for superficial with deep venous reflux). Bandages were applied in four layers with spinal turns on foot and turns in eight on calf. The bandages were worn day (10 – 12 hours) and put off on night. Patients in group D were treated with two layer short-stretch bandaging. The pressure values were also standardized in use of Kikuhime manometer (20–25 mmHg for superficial reflux and 25–30 mmHg for superficial with deep venous reflux). Treatment was with the same methodology as in group C. Patients from group E underwent the compression treatment by means of Unna's boot. After rinsing the wound with physiological sodium chloride solution, Unna's rigid paste bandage was tied around the limbs from below the toes up to the knee. This dressing was changed every 7 days. In all groups therapy lasted two months. The compressions were applied by a clinic physiotherapist, who was a professional practitioner (with 15 years of experience). The therapist completed a course on management of leg ulcers and additional training before experiment (20 days to practice applying bandaging with Kikuhime manometer).

The measurements:
The therapy progress was assessed using analysis of healing rates and digital planimetry - total ulcer surface area (cm2), length and width (cm), volume (cm3) – in use of digitizer
Intervention code [1] 288206 0
Treatment: Devices
Comparator / control treatment
Participants in control group provided only a standard regimen of drug therapy, including micronized purified flavonoid fraction 450 mg diosmin, 50 mg hesperidin, 2 tablets of 500 mg once daily
Control group
Active

Outcomes
Primary outcome [1] 290805 0
Primary outcome was analysis of changes of the total ulcer surface area, volume and linear dimensions inside observed groups

Tests/methods: digital planimetry
Timepoint [1] 290805 0
After two months therapy (compared to the baseline)
Secondary outcome [1] 305336 0
The secondary outcome was comparison between all groups the number of completely healed wounds (ulcer healing rates) and percentage change of ulcer surface area

Tests/methods: digital planimetry
Timepoint [1] 305336 0
After two months therapy (comparing changes between all groups)

Eligibility
Key inclusion criteria
Patients with venous leg ulcers were included in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were: (1) an ankle brachial pressure index (ABPI) lower than 1.0, (2) diabetes, (3) cancer, (4) peripheral nerve injury, (5) rheumatoid arthritis, (6) ventricular arrhythmia, (7) cardiac pacemaker, (8) ulcer surgery, (9) skin infection, (10) pregnancy and (11) after steroid therapy, (12) bilateral ulcers. The (13) lymphedema, (14) pulmonary edema and (15) congestive heart failure, (16) chronic renal failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer - generated random numbers were sealed in sequentially numbered envelopes and group allocation was independent of time and persons delivering the treatment. The physician allocating patients to groups had numbered envelopes, each containing a piece of paper marked with A, B, C, D and E groups. The physician would draw and open an envelope in the presence of a physiotherapist to see the symbol and direct the patient to one of the comparative groups accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer and numbered envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The chi - squared independence test and non-parametric Kruskal-Wallis two - way analysis, which is an element of a module of the analysis of variance, were used for comparing indicators, which characterized patients in all comparative groups. Outcome measurements were compared between the groups by using Fisher test, Kruskal-Wallis analysis of variance (post hoc Tukey’s test) and inside the groups non-parametric Wilcoxon signed - rank test. Two sided “P” (level of significance) values of less than 0.05 were considered to be statistically significant.

We had to use non-parametric statistical methods, because number of patients in each group was smaller than 30, which was unsufficient for parametric analysis (t-test or analysis of variance ANOVA) and normal the Gauss distribution. To achieve study obcjectives the minimal number of participants was 20 in each group (and 20 ulcers, because we included only patients with one wound on the leg). Smaller number of patients were not enough from both statistical and clinical point of view.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2010
Actual
14/06/2010
Date of last participant enrolment
Anticipated
25/01/2013
Actual
25/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
147
Accrual to date
Final
Recruitment outside Australia
Country [1] 5551 0
Poland
State/province [1] 5551 0
Silesia

Funding & Sponsors
Funding source category [1] 288201 0
University
Name [1] 288201 0
Medical University of Silesia
Country [1] 288201 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia
Address
Medykow 18 Street
40-752 Katowice, Poland
Country
Poland
Secondary sponsor category [1] 286927 0
None
Name [1] 286927 0
Address [1] 286927 0
Country [1] 286927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290113 0
The Research Ethics Committee from the Medical University of Silesia in Katowice, Poland
Ethics committee address [1] 290113 0
Poniatowskiego Street 15 40-055 Katowice
Ethics committee country [1] 290113 0
Poland
Date submitted for ethics approval [1] 290113 0
15/05/2006
Approval date [1] 290113 0
06/06/2006
Ethics approval number [1] 290113 0
NN/6501/101/06

Summary
Brief summary
Venous leg ulcers pose a serious clinical dilemma and an economic burden on health services. About 1%–2% of the whole population and 3%–5% of the population over 65 years of age will suffer from a leg ulcer during their lifetime. However, in a typical Western population where the average age is steadily increasing, the burden placed upon the health economy by venous ulceration looks set to increase proportionally. Cost effective treatment of venous disorders is therefore vital. Venous ulcers alone have been estimated to cost the National Health Service 400 million British Pounds a year in the United Kingdom. Studies in Germany calculated the mean total cost of a leg ulcer per patient per year to be 9569 Euros (8658 Euros - 92% direct costs). According to reports the financial burden of venous ulcers is estimated to be 2 billion American Dollars per year in the United States.
Clinical studies have examined the efficient effects of compression therapy on leg ulcers. But in the literature, there are many methods of applying external graduated compression, such as elasticised bandages, Unna’s boots, multilayer elastic compression bandages, short stretch bandages and elastomeric hosiery. The differences in effectiveness of various types of compression are not clear. The authors are still not sure as to which compression techniques, and pressure values are clinically the best, easy to use and not expensive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43954 0
Prof Andrzej Franek
Address 43954 0
Department of Medical Biophysics, Medical University of Silesia
Medykow Street 18, building C2 40 – 752 Katowice, Poland
Country 43954 0
Poland
Phone 43954 0
+48602474583
Fax 43954 0
Email 43954 0
[email protected]
Contact person for public queries
Name 43955 0
Prof Jakub Taradaj
Address 43955 0
Department of Physiotherapy Basics Academy School of Physical Education Mikolowska 72 Street 40-065 Katowice, Poland
Country 43955 0
Poland
Phone 43955 0
+48668613945
Fax 43955 0
Email 43955 0
[email protected]
Contact person for scientific queries
Name 43956 0
Prof Jakub Taradaj
Address 43956 0
Department of Physiotherapy Basics Academy School of Physical Education Mikolowska 72 Street 40-065 Katowice, Poland
Country 43956 0
Poland
Phone 43956 0
+48668613945
Fax 43956 0
Email 43956 0
[email protected]

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