Chronic Venous Leg UlcersPhase 2/3NCT00678847
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
A Phase 2/3 study testing KFH NOVO (inactive) + SCT and KFH Novo (BEST) + SCT in people with Chronic Venous Leg Ulcers, run by Kingfisher Healthcare at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Leg Ulcers
- What is being tested?
- KFH NOVO (inactive) + SCT and KFH Novo (BEST) + SCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gasthuisberg
Leuven, 3000
Mieke Flour, MD, maria.flour@uz.kuleuven.ac.be
Mieke Flour, MD
About this study
Indication: Subjects with chronic venous leg ulcers
Primary Objective:
Read more
- 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.
Read the detailed description
see above
- Conditions
- Chronic Venous Leg Ulcers
- Being tested
- KFH NOVO (inactive) + SCT, KFH Novo (BEST) + SCT
- Keywords
- bio-electrical stimulation therapy, chronic venous ulcers, microcurrent, chronic wounds, complete healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KFH NOVO (inactive) + SCTDevice
Also called KFH NOVO
inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
KFH Novo (BEST) + SCTDevice
Also called KFH Novo
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)
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | Not described Receives: Device: KFH NOVO (inactive) + SCT |
| A | Active comparator | Not described Receives: Device: KFH Novo (BEST) + SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers
Measured: every two weeks during treatment (8 weeks) and twice during follow-up period (8 weeks)
Secondary outcomes (1)
To evaluate pain
Measured: every two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kingfisher Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mieke Flour, MD, Study chair, UZ Gasthuisberg, Leuven (Belgium)Michel de la Brassinne, MD, Principal investigator, CHU Sart Tilman, Liege (Belgium)Bert Boyden, MD, Principal investigator, Virga Jesse Ziekenhuis, Hasselt (Belgium)Hilde Beele, MD, Principal investigator, University Hospital, GhentDiane Roseeuw, MD, Principal investigator, UZ Brussel (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678847
- Sponsor's protocol ID
- ULTRA-BEST
- Status last verified
- Mar 2008
- First submitted
- 14 Mar 2008
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
- ClinicalTrials.gov ID
- NCT00678847
- Acronym / sponsor ID
- ULTRA-BEST
- Conditions
- Chronic Venous Leg Ulcers
- Keywords
- bio-electrical stimulation therapy, chronic venous ulcers, microcurrent, chronic wounds, complete healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kingfisher HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Device: KFH NOVO (inactive) + SCT |
| A | Active comparator | Device: KFH Novo (BEST) + SCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KFH NOVO (inactive) + SCTAlso: KFH NOVOinactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT) | Device | B |
| KFH Novo (BEST) + SCTAlso: KFH Novo2 x 1 hour/day bio-electrical stimulation (BEST) for total period for total period of 8 weeks in combination with standardized conventional therapy (SCT) | Device | A |
Primary outcome
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)
1 secondary outcome
To evaluate pain
Time frame: every two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mieke Flour, MD study chair
UZ Gasthuisberg, Leuven (Belgium)
Michel de la Brassinne, MD principal investigator
CHU Sart Tilman, Liege (Belgium)
Bert Boyden, MD principal investigator
Virga Jesse Ziekenhuis, Hasselt (Belgium)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KFH NOVO (inactive) + SCT and KFH Novo (BEST) + SCT in people with Chronic Venous Leg Ulcers, run by Kingfisher Healthcare at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.