Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000056695
Ethics application status
Approved
Date submitted
7/01/2014
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Negative pressure therapy in wound healing
Scientific title
The application of negative pressure wound therapy in the treatment of chronic venous leg ulceration
Secondary ID [1] 283860 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical therapy in venous leg ulceration patients 290841 0
Efficiency analysis of the negative pressure treatment 290842 0
Condition category
Condition code
Cardiovascular 291205 291205 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 291206 291206 0 0
Other skin conditions
Physical Medicine / Rehabilitation 291257 291257 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study was to use negative pressure wound therapy (NPWT) in patients with chronic venous leg ulceration.

Intervention:
Negative pressure wound therapy was provided by the Genadyne A4TM system. The system consists of three components: a negative pressure generating unit with a disposable canister, a pad with evacuation tube, and a reticulated, open cell sterile polyurethane or a dense open-pore polyvinyl alcohol foam dressing cut to fit the wound. The system unit is programmed to deliver controlled negative pressure ranging from 50 to 200 mmHg (in repeating cycles automatically by the device: in every 3 minutes the pressure increased by 10 mmHg). Treatment was continued until ulcer closure, sufficient granulation tissue formation for healing by secondary intention. NPWT dressing changes were performed every 48-72 hours, no less than three times per week.

Measurements:
During the wound dressing and compression changes the area of the ulcers was constantly measured. The procedure was as follows. At the outset, homothetic congruent projections of the ulcers were plotted onto transparent foil, after which planimetric measurements of the wounds were taken with the use of digitizer Mutoh Kurta XGT-1218A3. The area of the ulcer was determined once a week until the wound healed completely.

All patients received also micronized flavonoid fraction (450 mg diosmin, 50 mg hesperidin), 2 tablets of 500 mg once daily (until ulcer closure, no stategies used to monitor adherence to the daily medication).
Intervention code [1] 288538 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 (until ulcer closure, no stategies used to monitor adherence to the daily medication).
Control group
Active

Outcomes
Primary outcome [1] 291195 0
Primary outcome was analysis of changes of the total ulcer surface area inside observed groups

Tests/methods: digital planimetry
Timepoint [1] 291195 0
After two months therapy (compared to the baseline)
Secondary outcome [1] 306214 0
The secondary outcome was comparison between both groups the number of completely healed wounds (ulcer healing rates) and percentage change of ulcer surface area

Tests/methods: digital planimetry
Timepoint [1] 306214 0
After two months therapy (comparing changes between both 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 and B 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 U-Mann Whitney analysis were used for comparing indicators, which characterized patients in all comparative groups. Outcome measurements were compared between the groups by matched pair Wilcoxon and U-Mann Whitney tests. 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) 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 (the smaller number of patients were not enough for reliable statistical analysis because of too large standard deviations due to different sizes of wounds). The reliable number of participants from wound diameters between 5 cm to 55 cm was estimated by Statistica 10 software, manufactured by StatSoft (licence of Academy School of Physical Education).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/12/2012
Actual
3/12/2012
Date of last participant enrolment
Anticipated
20/09/2013
Actual
20/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5718 0
Poland
State/province [1] 5718 0
Silesia

Funding & Sponsors
Funding source category [1] 288508 0
University
Name [1] 288508 0
Medical University of Silesia
Country [1] 288508 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia
Address
Poniatowskiego 15 Street
40-055 Katowice
Country
Poland
Secondary sponsor category [1] 287214 0
None
Name [1] 287214 0
Address [1] 287214 0
Country [1] 287214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290369 0
The Research Ethics Committee from the Medical University of Silesia in Katowice, Poland
Ethics committee address [1] 290369 0
Ethics committee country [1] 290369 0
Poland
Date submitted for ethics approval [1] 290369 0
15/05/2006
Approval date [1] 290369 0
06/06/2006
Ethics approval number [1] 290369 0
NN/6501/101/06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45350 0
Prof Marek Kucharzewski
Address 45350 0
Department of Descriptive and Topographic Anatomy, Medical University of Silesia, Jordana 19, 41-808 Zabrze
Country 45350 0
Poland
Phone 45350 0
+48660469080
Fax 45350 0
Email 45350 0
[email protected]
Contact person for public queries
Name 45351 0
Marek Kucharzewski
Address 45351 0
Department of Descriptive and Topographic Anatomy, Medical University of Silesia, Jordana 19, 41-808 Zabrze
Country 45351 0
Poland
Phone 45351 0
+48660469080
Fax 45351 0
Email 45351 0
[email protected]
Contact person for scientific queries
Name 45352 0
Marek Kucharzewski
Address 45352 0
Department of Descriptive and Topographic Anatomy, Medical University of Silesia, Jordana 19, 41-808 Zabrze
Country 45352 0
Poland
Phone 45352 0
+48660469080
Fax 45352 0
Email 45352 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.