Reduction of pain in patients with venous leg ulcers so that they will adhere to compression bandaging Circulatory System
Conditions
Interventions
Patients with painful venous leg ulcers will be randomised between the active sub-sensory electrostimulation device Accel-Heal or a placebo device that looks exactly the same. Accel-Heal is a low-vol
Sponsors
Accel-Heal Technologies Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with venous ulceration with excluded peripheral arterial disease using ABPI, TBPI or clinical assessment 2. Patients who report significant ulcer pain (above 4 on a 10-point numerical rating scale) despite analgesics 3. Patients who consent to being randomised to receive treatment either with Accel-Heal electrical stimulation in combination with compression therapy, or compression therapy with a non-active placebo Accel-Heal device 4. Patients whose ulcer is not circumferential 5. Patients who have not had their ulcer for more than 12 months 6. Patients whose ulcer area is greater than 1 cm²
Exclusion criteria
Exclusion criteria: 1. Patients who are under the age of 18 years 2. Patients who are unable to provide informed consent 3. Patients with ulcers of non-venous aetiology 4. Patients whose ulcers are not painful 5. Patients who are not prepared to try to receive effective levels of compression in combination with the Accel Heal electrical stimulation device for 12 days 6. Patients who are unable to undertake regular pain scores and keep a pain diary 7. Patients whose situation means that they cannot themselves or receive from carers a change of Accel-Heal every 2nd day 8. Patients who have had their ulcer for more than 12 months 9. Patients whose ulcer is circumferential 10 Patients whose ulcer area is 1cm² or less
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Neuropathic pain score using PainDetect assessment tool each day from baseline to day 14 2. Consumption of analgesics each day from baseline to day 14 3. Number of days without prescribed compression from baseline to day 14measured by self report 4. Number of patients recruited per unit time measured throughout 5. Frequency of patients withdrawing and completing the study measured throughout using patient records 6. Telephone or face-to-face interview about pain; completed at removal of Accel-Heal to discuss how bad the pain was, what patients tried to do about it (or not), how effective their efforts to reduce pain were, pain interference with life, and pain interference with compression therapy. SF-12 score for quality of life (or equivalent) recorded at enrolment, removal of Accel Heal, and end of the 6-week study 7. Ulcer area; measured at enrolment, removal of Accel Heal, and end of the 6-week study 8. Wound bed and peri wound skin; assessed at enrolment, removal of Accel Heal and end of the 6-week study | — |
Primary
| Measure | Time frame |
|---|---|
| Pain measured using the Brief Pain Inventory score recorded each day from baseline to day 14 | — |
Countries
England, United Kingdom
Contacts
Public ContactRobin Martin
Outcome results
None listed