Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

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.

Conditions

• Chronic Venous Leg Ulcers

Interventions

DEVICE

KFH NOVO (inactive) + SCT

inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)

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)

Sponsors & Collaborators

• Kingfisher Healthcare

  lead INDUSTRY

Principal Investigators

• Mieke Flour, MD · UZ Gasthuisberg, Leuven (Belgium)

• Michel de la Brassinne, MD · CHU Sart Tilman, Liege (Belgium)

• Bert Boyden, MD · Virga Jesse Ziekenhuis, Hasselt (Belgium)

• Hilde Beele, MD · UZ Gent, Belgium

• Diane Roseeuw, MD · UZ Brussel (Belgium)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2009-03-31

Completion

2009-03-31

Countries

• Belgium

Study Locations