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View Clinical Trial (Medical Research Study)
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Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers - NCT00558662-Tiel - 007 (Clinical Trial 191220)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy191220.aspx
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| City: |
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Tiel |
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Country:
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Netherlands |
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| Conditions: |
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Venous Ulcer |
| Purpose: |
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The study purpose is to compare healing rates, cost effectiveness, quality of life and
safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™
Coban™ 2 Layer Compression System versus short-stretch compression bandage.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Males or females, age 18 years or older
- Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous
pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any
dimension but not larger than 10 cm in any dimension and has at least 5 cm distance
to additional ulcers.
- Subjects who are co-operative, willing to give written informed consent prior to
study entry, and willing to comply with the study protocol.
- Subjects who are able to understand and answer questionnaire items.
- Subjects who can walk (with or without a walking aid).
- Subjects who have an ABPI (ankle brachial pressure index) of treated leg greater or
equal to 0,8 as measured within four weeks prior to enrollment.
- Subjects with venous incompetence as defined by reflux longer than 1,0 second in at
least one of the following sites: groin [femoral vein, junction of GSV], mid thigh
medial [GSV], hollow of the knee [popliteal vein, junction of SSV], mid calf [SSV] in
the standing position, measured by Doppler, preferably by duplex within the last 12
month without following active treatment of venous reflux.
Exclusion Criteria:
- Subjects with an ABPI < 0.8 as measured within four weeks prior to enrollment.
- Subjects whose condition, in the opinion of the investigator, does not require or
allow for compression therapy.
- Subjects where the potential study ulcer is infected, i.e. showing signs of clinical
infection (not contamination) as evidenced by purulent, malodorous, or recent
increase in drainage and/or peri-wound erythema or elevated temperature.
- Subjects receiving any systemic antibiotics.
- Subjects with diagnosed cancerous ulceration.
- Subjects with diabetic foot ulcers (do not exclude diabetics).
- Subjects with circumferential wounds.
- Subjects who started or significantly changed treatment with mood altering substances
(e.g. antidepressant drugs) within two weeks prior to enrollment.
- Subjects who are participating in any prospective clinical study that can potentially
interfere with this study.
- Subjects who are, in the opinion of the clinical investigator, unsuitable for
enrollment in this study, for reasons not specified in the exclusion criteria.
- Subjects with known allergies against the following products: Coban 2 Layer
Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF |
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| Study is available at: |
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Rivierenland Ziekenhuis, Department of Dermatology
Tiel
Netherlands
Primary Contact:
O. Q. J. Swinkels, MD PhD
Email: q.swinkels@zrt.nl
Phone: +31 6 169 64 125
Secondary Contact:
Sabine Heiligtag
Email: sheiligtag@mmm.com
Phone: +49 (0) 2131/14 - |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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