Health Condition 1: I739- Peripheral vascular disease, unspecified Health Condition 2: E105- Type 1 diabetes mellitus with circulatory complications Health Condition 3: E115- Type 2 diabetes mellitus with circulatory complications Health Condition 4: I872- Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Intervention1: NIL: NIL - this is observational trial
Control Intervention1: NIL: NIL - this is observational trial
Sponsors
Firstkind Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years 2. Patients who are diagnosed with a diabetic foot ulcer 3. Intact healthy skin at the site of geko™ device application. 4. Willing and able to give written informed consent 5. Identified to receive geko™ therapy as part of their standard care for wound management.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding 2. Use of any other neuro-modulation device. 3. Current use of TENS in the pelvic region, back or legs 4. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. 5. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Frequency of adverse events Obtain frequency of adverse events (AEs) & serious AEs (SAEs) whether device related or not & compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy 2.Frequency of device deficiencies Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy 3. Summary of routinely tested and collected performance data Obtain routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e., geko™ therapy vs standard care without geko™ therapyTimepoint: Up to 12 months from study entry | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomesTimepoint: Up to 84 days from study entry | — |
Countries
India, United Kingdom, United States of America
Contacts
Public ContactDr Sanjay Vaidya
Firstkind Ltd
Outcome results
None listed