A study to explore the benefits of electrical stimulation with the Accel-Heal device on patients with painful venous leg ulcers

Not Applicable

Completed

• Conditions: Reduction of pain in patients with venous leg ulcers so that they will adhere to compression bandaging; Circulatory System

• Registration Number: ISRCTN42415713
• Lead Sponsor: Accel-Heal Technologies Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Study Completion: 2022-09-30
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured using the Brief Pain Inventory score recorded each day from baseline to day 14