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Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Primary Purpose

Venous Ulcer

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Coban 2

SSB

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring compression therapy, venous leg ulcer, sub bandage pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wound Centre AZ St. Elisabeth
AZ Alma Eeklo
Military Hospital Queen Astrid
Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken
Klinik und Poliklinik für Dermatologie der Universität Bonn
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Prof. Vanscheidt, MD, PhD
Klinikum Lippe_lemgo
Kliniken Maria Hilf
Ziekenhuis de Lievensberg, Department of Dermatology
IJsselland Hospital
Atrium Medisch Centrum Parkstad in Heerlen
Dr. Kolbach Kliniek
Wound Healing Research unit, Cardiff Medicentre
Tissue Viability
Trowbridge Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Coban 2 Layer Compression System

Short-Stretch Bandage

Outcomes

Primary Outcome Measures

- venous leg ulcer healing

Secondary Outcome Measures

- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE

Full Information

NCT ID

NCT00558662

First Posted

November 13, 2007

Last Updated

November 17, 2011

Sponsor

1. Study Identification

Unique Protocol Identification Number

NCT00558662

Brief Title

Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Official Title

Randomized Controlled Clinical Study to Assess the Clinical Efficacy of the 3M™ Coban™ 2 Layer Compression System Compared to a Short-stretch Compression Bandage in the Treatment of Venous Leg Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Ulcer

Keywords

compression therapy, venous leg ulcer, sub bandage pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

234 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Coban 2 Layer Compression System

Arm Title

Arm Type

Active Comparator

Arm Description

Short-Stretch Bandage

Intervention Type

Device

Intervention Name(s)

Coban 2

Other Intervention Name(s)

Coban 2 Layer Compression System

Intervention Description

Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.

Intervention Type

Device

Intervention Name(s)

SSB

Other Intervention Name(s)

Rosidal K, Rosidal soft

Intervention Description

Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.

Primary Outcome Measure Information:

Title

- venous leg ulcer healing

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: