Varicose Veins Clinical Trial
— CCLINSOfficial title:
Prospective Observational Series to Establish the Haemodynamic Efficacy and Tolerability of gekoTM Device in Patients With Lower Limb Vascular Disease
NCT number | NCT01942941 |
Other study ID # | 12/EE/0314 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2013 |
Est. completion date | May 2014 |
Verified date | July 2019 |
Source | Hull and East Yorkshire Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18 years - Absence of haematological disorders or DVT (deep vein thrombosis) in the preceding 12 months - Intact cutaneous sensations to nocioception in the lower limb, as determined by the investigator - Intact healthy skin at site of application - On effective contraception if sexually active - oral contraceptive pill (> 3 months use), condoms, intrauterine contraceptive device, depot injection - Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements Exclusion Criteria: - History of haematological disorder or DVT in the preceding 12 months - Pregnant or planning to become pregnant during study duration - Pacemakers or implantable defibrillators - Use of any other neuro-modulation device - Current use of TENS (transcutaneous electrical nerve stimulation) in pelvic region, back or legs - Use of investigational drug/device therapy within past 4 weeks that may interfere with this study. - Significant varicose veins or lower limb ulceration. - Recent surgery (such as abdominal, gynaecological, hip knee replacement). - Recent trauma to lower limbs. - Chronic Obesity (BMI Index >34). - Any medication judged to be significant by the Principal Investigator. - Any significant illness during the four (4) weeks preceding the screening period of the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hull Royal Infirmary | Hull | EastRiding Of Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull and East Yorkshire Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of geko™ on blood volume flow through the femoral artery | Measured with ultrasound doppler | Study day i.e. 1 day | |
Secondary | Effect of geko™ on venous blow flow | Measured with ultrasound doppler | Study day i.e. 1 day | |
Secondary | Effect of geko™ on microcirculatory flow | Measured with laser doppler | Study day i.e. 1 day | |
Secondary | Establish whether effects of geko™ are local or systemic | Measurements will be taken from both the leg on which the device is active and the leg with no geko™ | Study day i.e. 1 day | |
Secondary | Effect of geko™ on patients symptoms | Completion of McGill pain questionnaire and visual analogue scale | study day i.e. 1 day | |
Secondary | Acceptability and tolerability of geko™ device | Completion of tolerability questionnaire | study day i.e. 1 day | |
Secondary | Effect of gekoTM on calf circumference | Calf circumference measured before and after device | Study day i.e. 1 day |
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