Geko Venous Leg Ulcer Study

Launched by FIRSTKIND LTD · Jun 24, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Intact healthy skin at the site of device application
• • 3. Able to understand the Patient Information Sheet
• • 4. Willing to give informed consent
• • 5. Willing to follow the requirements of the protocol
• • 6. Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
• • 7. ABPI of 0.8 or greater
• Exclusion Criteria:
• • 1. History of significant haematological disorders or DVT with the preceding six months
• • 2. Pregnant
• • 3. Pacemakers or implantable defibrillators
• • 4. Use of any other neuro-modulation device
• • 5. Current use of TENS in pelvic region, back or legs
• • 6. Use of investigational drug or device within the past 4 weeks that may interfere with this study
• • 7. Recent surgery (such as abdominal, gynaecological, hip or knee replacement)
• • 8. Recent trauma to the lower limbs
• • 9. Size of leg incompatible with the geko™ device.
• • 10. Chronic obesity (BMI \> 34)
• • 11. Any medication deemed to be significant by the Investigator
• • 12. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension
• • 13. Diabetic subjects with advanced small vessel disease