Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

NCT00678847 | Unknown Phase 2

• 1 other identifier: ULTRA-BEST
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Leg Ulcers

Keywords

bio-electrical stimulation therapy; chronic venous ulcers; microcurrent; chronic wounds; complete healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate pain

  every two weeks

Study Arms (2)

B

PLACEBO COMPARATOR

Device: KFH NOVO (inactive) + SCT

A

ACTIVE COMPARATOR

Device: KFH Novo (BEST) + SCT

Interventions

KFH NOVO (inactive) + SCT DEVICE

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

Also known as: KFH NOVO

B

KFH Novo (BEST) + SCT DEVICE

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)

Also known as: KFH Novo

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kingfisher Healthcare: lead

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Study Officials

• Mieke Flour, MD

  UZ Gasthuisberg, Leuven (Belgium)

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: May 16, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 16, 2008

Record last verified: 2008-03

Locations

BE (1)