Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Venous Leg Ulcers |
Device: KFH NOVO (inactive) + SCT Device: KFH Novo (BEST) + SCT |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy |
- To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers [ Time Frame: every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks) ] [ Designated as safety issue: Yes ]
- To evaluate pain [ Time Frame: every two weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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 Name: KFH Novo
|
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Belgium | |
| UZ Gasthuisberg | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Mieke Flour, MD maria.flour@uz.kuleuven.ac.be | |
| Principal Investigator: Mieke Flour, MD | |
| 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) |
More Information
No publications provided
| Responsible Party: | Dr. Henk Snyman, Kingfisher Healthcare |
| ClinicalTrials.gov Identifier: | NCT00678847 History of Changes |
| Other Study ID Numbers: | ULTRA-BEST |
| Study First Received: | March 14, 2008 |
| Last Updated: | May 15, 2008 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Kingfisher Healthcare:
|
bio-electrical stimulation therapy chronic venous ulcers microcurrent chronic wounds complete healing |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Varicose Ulcer Skin Ulcer Skin Diseases |
Pathologic Processes Varicose Veins Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013