Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Sponsor

Kingfisher Healthcare (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00678847

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Venous Leg Ulcers	Device: KFH NOVO (inactive) + SCT Device: KFH Novo (BEST) + SCT	Phase 2/Phase 3

Detailed Description

see above

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Study Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: KFH Novo

Arm

Intervention/Treatment

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 Names:

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 Names:

KFH Novo

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers [every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks)]

Secondary Outcome Measures

To evaluate pain [every two weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UZ Gasthuisberg	Leuven		Belgium	3000

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)