Chronic Venous ULcer TReatment Analyzing Bio-Electrical S... | NCT00678847

Studies
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

NCT00678847

Sponsor

Kingfisher Healthcare

Status

Unknown status

Last Update Posted

May 16, 2008Estimated

Enrollment

50Estimated

Phase

Phase 2Phase 3

Conditions

Chronic Venous Leg Ulcers

Interventions

KFH NOVO (inactive) + SCT
KFH Novo (BEST) + SCT

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2009Estimated

Completion Date

Mar 2009Estimated

First Submitted Date

Mar 14, 2008

First Submission Date that Met QC Criteria

May 15, 2008

First Posted Date

May 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2008

Last Update Posted Date

May 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

see above

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Placebo Comparator		Device: KFH NOVO (inactive) + SCT
A	Active Comparator		Device: KFH Novo (BEST) + SCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KFH NOVO (inactive) + SCT	Device	inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)	B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To evaluate pain		every two weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Gasthuisberg	Recruiting	Leuven		3000	Belgium