A study to explore the benefits of electrical stimulation with the Accel-Heal device on patients with painful venous leg ulcers
| ISRCTN | ISRCTN42415713 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42415713 |
| IRAS number | 279505 |
| Secondary identifying numbers | AH-1 2019, IRAS 279505 |
- Submission date
- 09/02/2021
- Registration date
- 15/02/2021
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Nearly 2 out of every 100 people in the UK has the misfortune to develop a venous leg ulcer. This happens because disease in the blood vessels in the lower parts of the leg makes blood collect which leads to swelling, reduced oxygen and eventually an ulcer. It is already known that wrapping a compressing bandage around the leg is proven to be the most effective treatment and if this happens many ulcers will heal.
Unfortunately, venous leg ulcers are often painful and in many cases this makes patients reluctant to accept a compressing bandage which means their ulcers will take much longer to heal. Pain killing medicine can be used, but often these drugs don’t work well on ulcer pain. The purpose of this study is to test whether a small, disposable device called Accel-Heal® which applies a tiny electric current to the ulcer, can reduce the pain and allow more patients to accept compressing bandages. Patients can’t feel the electric current. Patients will wear the devices for a total of 12 days and keep a diary of how much pain they were feeling, what medicines they have taken and whether they were able to wear the compressing bandages.
Who can participate?
Patients aged 18 years or above, with leg ulcers that meet the inclusion cirteria.
What does the study involve?
Forty patients will be asked to join the study by adult community nursing teams in Yorkshire and Northumbria. In order to carry out a fair test, half of the patients will be chosen by chance to wear the real device, whilst half of the patients will wear a dummy device that looks the same but gives no electric current. This study is a small-scale version of a future larger study to check whether the design is correct.
What are the possible benefits and risks of participating?
It is not anticipated that there will be a safety risk to any of the patients in this study from Accel-Heal. Accel-Heal has been on the UK market since 2008, during which time there have not been any serious harm associated with the device. If the active Accel-Heal devices are able to reduce pain, it will be of an immediate benefit to the patients in the study: it may reduce the amount of pain medicine they are taking and may enable patients to tolerate compression bandaging which known to be an effective therapy for this type of ulcer.
Where is the study run from?
Mid Yorkshire Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
November 2019 to September 2022
Who is funding the study?
Accel-Heal Technologies Ltd (UK)
Who is the main contact?
Dr Leanne Atkin, leanne.atkin1@nhs.net
Dr Robin Martin, robin@robinmartinphd.com
Contact information
Scientific
3 Manor Farm Barns
Foggathorpe
Selby
YO8 6PZ
United Kingdom
 ORCID ID |
0000-0002-9314-0437 |
|---|---|
| Phone | +44 (0)7736736752 |
| robin@robinmartinphd.com |
Public
3 Manor Farm Barns
Foggathorpe
Selby
YO8 6PZ
United Kingdom
| ORCID ID |
0000-0002-9314-0437 |
|---|---|
| Phone | +44 (0)7736736752 |
| robin@robinmartinphd.com |
Scientific
University of Huddersfield
Huddersfield
HD1 3DH
United Kingdom
| ORCID ID |
0000-0002-4830-1967 |
|---|---|
| Phone | +44 (0)1484 472905 |
| leanne.atkin1@nhs.net |
Study information
| Study design | Multicenter interventional pilot randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A pilot randomised controlled trial exploring the effects of the Accel-Heal electrical stimulation device in VLU patients reporting significant pain. |
| Study hypothesis | The overall objective is to pilot the study design for a future RCT assessing the ability of the Accel-Heal electrical stimulation device to reduce pain in venous leg ulcer patients so that they remain in concordance with their prescribed compression therapy. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Reduction of pain in patients with venous leg ulcers so that they will adhere to compression bandaging |
| Intervention | 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-voltage biphasic and monophasic pulsedcurrent (LVBMPC) electrical stimulation device consisting of 2 adhesive electrode pads connected to a disposable power unit. Therapy is provided for 12 days as 6 x 2-day units. Accel-Heal is designed to stimulate and promote venous leg ulcer healing using a pattern of subsensory bioelectrical pulses. It is used alongside standard care including compression therapy. Patients will be randomised using randomised blocks of size 2, using opaque sealed envelopes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Accel-Heal, UDI 17000545 |
| Primary outcome measure | Pain measured using the Brief Pain Inventory score recorded each day from baseline to day 14 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2019 |
| Overall study end date | 30/09/2022 |
| Reason abandoned (if study stopped) | Study was not started. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2021 |
| Recruitment end date | 30/05/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Rake lane
North Shields
NE29 8NH
United Kingdom
Sponsor information
Industry
Hever Business Centre
Hever
TN8 7ER
United Kingdom
| Phone | +44 (0)7717291183 |
|---|---|
| jwootten@accelheal.com | |
| Website | https://www.accelheal.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer review journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
10/10/2023: The study was marked stopped. The study never started.
15/02/2021: Trial’s existence confirmed by Accel Heal.
