Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Chronic Venous Leg Ulcers Clinical Trial

Official title:

Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00678847
• Other study ID #: ULTRA-BEST
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 14, 2008
• Last updated: May 15, 2008
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2008
• Source: Kingfisher Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Leg Ulcers
• Ulcer
• Varicose Ulcer

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Kingfisher Healthcare

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	To evaluate pain		every two weeks	Yes