Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Kingfisher Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kingfisher Healthcare
ClinicalTrials.gov Identifier:
NCT00678847
First received: March 14, 2008
Last updated: May 15, 2008
Last verified: March 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Resource links provided by NLM:


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
Placebo Comparator: B Device: KFH NOVO (inactive) + SCT
inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
Other Name: KFH NOVO
Active Comparator: A 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)
Other Name: KFH Novo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Dr. Henk Snyman, Kingfisher Healthcare
ClinicalTrials.gov Identifier: NCT00678847     History of Changes
Other Study ID Numbers: ULTRA-BEST
Study First Received: March 14, 2008
Last Updated: May 15, 2008
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

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014