Chronic Venous Leg Ulcers
Conditions
Keywords
bio-electrical stimulation therapy, chronic venous ulcers, microcurrent, chronic wounds, complete healing
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
Interventions
DEVICEKFH NOVO (inactive) + SCT
inactive device (placebo) 2 x 1hour/day for total period of 8 weeks + standardized conventional therapy (SCT)
DEVICEKFH 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)
Sponsors
Kingfisher Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To evaluate pain | every two weeks |
Countries
Belgium
Outcome results
None listed