Status:
COMPLETED
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
Lead Sponsor:
Professor Stewart Walsh
Conditions:
Chronic Venous Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression b...
Detailed Description
With an increasingly ageing population the incidence of venous ulceration is likely to rise. The negative impact of leg ulceration on patients' quality of life and on healthcare costs is well recognis...
Eligibility Criteria
Inclusion
- Primary or recurrent venous leg ulcer.
- Ankle-brachial pressure index \> 0.8
- Ulcer size between 1 and 200 cm2
- Patient suitable for full compression bandaging
Exclusion
- History of symptomatic heart disease.
- Pregnancy
- Presence of implants in the lower leg or a pacemaker
- History of a neurological disorder
- Presence of any contraindications for the use of compression stockings such as severe arterial disease i.e. Ankle brachial pressure index (ABPI) \<0.8
- Presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator appropriately.
- Patients unable to provide informed consent
- Patients receiving dialysis
- Patients receiving steroids
- Patients receiving methotrexate
- Ulcer located in the area of electrode placement
- Patients in reduced compression bandaging system
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01801891
Start Date
May 1 2013
End Date
October 1 2014
Last Update
December 12 2014
Active Locations (2)
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1
Department of Electronic Engineering, National University Ireland Galway
Galway, Ireland, 000
2
MidWestern Regional Hospital
Limerick, Ireland, 000