Status:
COMPLETED
Efficacy Study for Geko Device in VLU Patients
Lead Sponsor:
Firstkind Ltd
Conditions:
Venous Leg Ulcer
Leg Ulcers Venous
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase). To compare two daily geko™ device t...
Detailed Description
1. Screen patient database to identify eligible patients 2. Obtain informed consent and inform participant's GP 3. Complete CRF throughout the study period (demographics, vital signs, medical history,...
Eligibility Criteria
Inclusion
- Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.
- Male or female aged ≥ 18 years and able to provide written informed consent.
- Intact healthy skin at the site of gekoTM device application.
- Patients who have a chronic venous leg ulcer determined to be due to underlying venous disease following evaluation in a multidisciplinary clinic setting.
- A VLU of approximately ≥ 3cm2 and ≤ 39 cm2 at study enrolment i.e. Run In Phase Visit 1 (RV1). The largest ulcer within the given size range will be designated the study ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart if they are separate wounds.
- Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry (i.e. RV1).
- Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry (i.e. RV1).
- No active local or systemic infection for a minimum of 48 hours prior to study entry (i.e. RV1).
- No systemic antimicrobial treatment for a minimum of seven days prior to study entry prescribed for index wound infection (i.e. RV1).
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
- Note: At the randomisation visit, the study ulcer needs to be ≥ 2 cm2 and ≤ 30 cm2.
Exclusion
- Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomisation:
- Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy.
- History of significant haematological disorders (e.g. Sickle Cell disease).
- History of Deep Vein Thrombosis (DVT) within six months preceding study entry (i.e. RV1).
- History of Pyoderma Gangrenosum or other inflammatory ulceration.
- Pregnancy or breast feeding.
- Use of investigational drug or device within four weeks prior to study entry (i.e. RV1) that may interfere with this study.
- Use of any neuro-modulation device.
- Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement) (i.e. RV1).
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
- Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids).
- Participation in any other clinical study.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT03396731
Start Date
April 24 2018
End Date
August 9 2022
Last Update
September 21 2023
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Trafalgar Group Medical Practice
Southsea, Portsmouth, United Kingdom, PO5 3ND
2
Crouch Oak Family Practice
Addlestone, United Kingdom, KT15 2BH
3
Barnsley Hospital NHS foundation Trust
Barnsley, United Kingdom, S75 2EP
4
Heart of Bath Medical Partnership
Bath, United Kingdom, BA2 3HT