Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy - Full Text View

Sponsored by:	Kingfisher Healthcare
Information provided by:	Kingfisher Healthcare
ClinicalTrials.gov Identifier:	NCT00678847

Purpose

Indication: Subjects with chronic venous leg ulcers

Primary Objective:

• To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers

Secondary Objective(s):

To evaluate the percentage of wound healing every two weeks
To evaluate the complete ulcer healing every two weeks
To evaluate the time to complete ulcer healing
To evaluate the recurrence rate at the end of the follow-up period
To evaluate pain
To evaluate the quality of life

Study Design and Treatment Scheme:

This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective study in which data will be collected of subjects with chronic venous leg ulcers receiving standardized conventional therapy (SCT). Subjects will be randomized into two groups receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the effect of BEST on the wound healing process.

Patients answering the eligibility criteria will receive standardized conventional therapy during 4 weeks before actual study start and will then again be evaluated on eligibility according to wound healing rate. Only patients with a wound surface that has not significantly changed (both increased or decreased) will be randomized in the treatment period.

During the treatment period patients will receive SCT with placebo or SCT in combination with bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks.

Patients will be in follow-up period for a maximum of 8 weeks after treatment period.

Condition	Intervention	Phase
Chronic Venous Leg Ulcers	Device: KFH NOVO (inactive) + SCT Device: KFH Novo (BEST) + SCT	Phase II Phase III

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Further study details as provided by Kingfisher Healthcare:

Primary Outcome Measures:

To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers [ Time Frame: every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate pain [ Time Frame: every two weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Placebo Comparator	Device: KFH NOVO (inactive) + SCT inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
A: Active Comparator	Device: KFH Novo (BEST) + SCT 2 x 1 hour/day bio-electrical stimulation (BEST) for total period for total period of 8 weeks in combination with standardized conventional therapy (SCT)

Detailed Description:

see above

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult subjects ≥ 18 years old, male or female
Before any subject data is collected, the appropriate written informed consent must be obtained (see appendix H).
Confirmation of venous insufficiency during the last 5 years by Duplex examination
Chronic venous leg ulcers (>12 weeks) not healing with conventional therapy
Study ulcer size between 8 to 20 cm² and without clinical signs of infection
No presence of other ulcers in a radius of 5 cm around the study ulcer
No surgery for venous insufficiency within the last 6 months
No arterial insufficiency (ABI between 0,7 and 1,3)
BMI < 40
No uncontrolled diabetes or any uncontrolled systemic condition that might impair wound healing
No decubitus wounds
Ambulant subject
Written informed consent

Exclusion Criteria:

Subjects with implanted electrical devices (e.g. cardiac pacemakers)
Subjects having a concurrent malignancy or being less than 3 years after the end of their cancer therapy
Subjects with active osteomyelitis
Pregnant or breast-feeding women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678847

Locations

Belgium
UZ Gasthuisberg	Recruiting
Leuven, Belgium, 3000
Contact: Mieke Flour, MD maria.flour@uz.kuleuven.ac.be
Principal Investigator: Mieke Flour, MD

Sponsors and Collaborators

Kingfisher Healthcare

Investigators

Study Chair:	Mieke Flour, MD	UZ Gasthuisberg, Leuven (Belgium)
Principal Investigator:	Michel de la Brassinne, MD	CHU Sart Tilman, Liege (Belgium)
Principal Investigator:	Bert Boyden, MD	Virga Jesse Ziekenhuis, Hasselt (Belgium)
Principal Investigator:	Hilde Beele, MD	UZ Gent (Belgium)
Principal Investigator:	Diane Roseeuw, MD	UZ Brussel (Belgium)

More Information

Responsible Party:	Kingfisher Healthcare ( Dr. Henk Snyman )
Study ID Numbers:	ULTRA-BEST
Study First Received:	March 14, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00678847
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Kingfisher Healthcare:

bio-electrical stimulation therapy
chronic venous ulcers
microcurrent
chronic wounds
complete healing

Study placed in the following topic categories:

Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer

Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009