Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Kingfisher Healthcare

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Chronic Venous Leg Ulcers

Treatments

Device: KFH NOVO (inactive) + SCT

Device: KFH Novo (BEST) + SCT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00678847

ULTRA-BEST

Details and patient eligibility

About

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.

Full description

see above

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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