Electrical Stimulation Frequency Comparison Study
Research type
Research Study
Full title
Electrical Stimulation Waveform Frequency Comparison in Temporal Punch Biopsies In a Human Volunteer, Randomised, Parallel Group, Assessor - Blinded Study
IRAS ID
206364
Contact name
Kenneth Hugh
Contact email
Sponsor organisation
Oxford Bioelectronics Limited
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
This is a study to demonstrate the effect of different electrical stimulation waveform frequencies from a device on wound healing using a small "punch" biopsy on the skin of the upper arm.
Twenty one healthy male and female subjects will be enrolled at BioKinetic. At the screening visit, 21 days before the start of the study, volunteers will give consent and will be assigned into three groups. They will then undergo screening procedures.
There will be 11 outpatient visits.
The treatments will be parallel, randomised and assessor-blind.
Treatment Group 1 - device set to frequency cycle mode and applied for 40 minutes (frequency 30Hz - 120 Hz, rate is 1Hz every 30mS)
Treatment Group 2 - device set to 85Hz and applied for 40 minutes.
Treatment Group 3 - device set to 60Hz for 10 minutes, 90Hz for 10 minutes, 120Hz for 10 minutes and 10 minutes in frequency cycle mode (30Hz - 120Hz).On Day 0 of the study a 5 mm round punch biopsy wound will be created in both the left and right upper inner arm. The volunteers will act as their own control, as the wound created by the biopsy on one arm will be treated by electrical stimulation while the other will heal normally without intervention. The investigator will observe and monitor normal wound healing by non-invasive methods.
Photographs will be taken to monitor the size and appearance of the wound site, and any skin colour changes. Non-invasive measurement tools include, Full-field laser perfusion imaging and chroma-meter which allow assessment of new blood vessel growth which indicates wound repair.
Blood samples will be taken to assess blood count and certain proteins. Subject assessment questionnaires will be used to score symptoms experienced on the treated arm.
The outpatient visits will be consecutive from Day 0 to Day 9, returning on Day 16 for assessment, and post study physical.
REC name
HSC REC B
REC reference
16/NI/0132
Date of REC Opinion
11 Jul 2016
REC opinion
Favourable Opinion