Chronic Venous Leg Ulcers Clinical Trial
Official title:
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
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.
see above ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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