Intermittent Pneumatic Compression Of the Thigh (IPCOTT)
Research type
Research Study
Full title
Intermittent Pneumatic Compression Of the Thigh for the Treatment of lower limb wounds: a randomised control trial.
IRAS ID
285979
Contact name
Dr Jane Davies
Contact email
Sponsor organisation
Huntleigh Healthcare Ltd
ISRCTN Number
ISRCTN77093550
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Research Summary
The aim of the study is to compare how effect using a thigh administered intermittent compression therapy (IPC) called WoundExpress is at healing wounds. The IPC will be used with a compression bandage as a treatment for patients with a lower leg wound called a venous leg ulcer. The combination of IPC and bandage will be compared to patients having a bandage alone to compare which helps heal the leg ulcer quicker. WoundExpress comprises of 2 parts- a thigh garment which attaches to a pump. The thigh garment is wrapped around the top of the thigh and attaches to a machine which inflates the thigh garment. The pressure applies a pressure of 60 mmHg which inflates and deflates over a 2-minute cycle. The patient will be asked to wear the IPC daily for 2 hours. As this is a randomised study patients will either have bandages alone or bandage and IPC. The patients will be asked to attend the research clinic on 10 occasions. When the patients attend the research clinic a research nurse will take, the bandages will be removed the wound cleansed and a photograph of the wound which will be measured and assessed for signs of infection and the pain experienced by the patient will also be recorded. The patient will be asked how comfortable the treatment that has been allocated has been over the previous week
Summary of Results
Background and why this study was needed Chronic wounds on the lower legs are common, especially in older adults. Venous leg ulcers (VLUs) occur when blood flow in the leg veins is poor. Mixed aetiology leg ulcers (MLUs) occur when a venous ulcer is combined with another problem such as mild arterial disease. These ulcers can be painful, slow to heal and expensive for health services. Standard treatment uses static compression (for example, bandages or special stockings) to support blood flow, but many ulcers take months or years to heal.
Intermittent pneumatic compression (IPC) is a therapy that uses a pump connected to an inflatable sleeve to rhythmically squeeze the limb. This squeezing mimics the action of muscles and helps blood and lymph to return towards the heart. The present study wanted to investigate whether adding thigh administered IPC to standard care would help hard to heal leg ulcers close more quickly. The WoundExpress™ device that was used in this study delivers IPC to the thigh through a sleeve with three chambers. Each four minute compression cycle alternates inflation and deflation to improve both venous and arterial blood flow and remove waste products.
Who organised and funded the study
This clinical investigation, called IPCOTT (Intermittent Pneumatic Compression Of the Thigh for the Treatment of lower limb wounds: a randomised control trial), was sponsored by Huntleigh Healthcare Ltd and jointly funded by the Welsh Government, the European Regional Development Fund and the sponsor. The study was approved by research ethics committees in the participating countries and registered on public trial registries.
Where and when it took place
The trial ran from April 2021 to April 2024 and was conducted in four countries (United Kingdom, Germany, France and the United States). The intention was to enrol 160 participants, but recruitment stopped at 136 participants because the COVID 19 pandemic disrupted study activities.
Who took part
Adults with at least one hard to heal venous or mixed aetiology lower limb ulcer were eligible. Participants had already been receiving appropriate compression therapy for at least four weeks and agreed to continue this and apply IPC for 2 hours daily during the study. People with very large wounds (>100 cm²), very short (<2 months) or very long (>5 years) wound duration, uncontrolled diabetes or other conditions that make IPC unadvised were excluded.
The 136 participants were evenly distributed between the two study arms (65 in the IPC group and 71 in the control group). The average age was 66 years and ages ranged from 28 to 93. Just over 57 % were male, and 77.9 % were of White ethnic origin. Baseline weight, height and ankle size were similar between groups. Most wounds were 30 cm² or smaller (86 % of participants), and 52 % of participants had been living with their wound for 12 months or less. Wounds were mainly located on the calf, ankle or gaiter area (the lower calf above the ankle).
What happened in the study
After a two week run in period to optimise wound care, participants were randomly assigned to one of two groups:
• IPC + standard care (intervention group): participants continued their usual compression therapy and other wound care and used the WoundExpress™ IPC device at home for two hours every day for 16 weeks. The device recorded usage, and participants kept a diary of when they wore it.
• Standard care alone (control group): participants continued their usual compression therapy (bandages, hosiery or wraps) and other wound care for 16 weeks without using IPC.
Follow up visits took place every two weeks, with final assessments at 16 weeks. Nurses measured the ulcer size with specialist software and asked participants about pain. Participants also completed questionnaires about their quality of life and how satisfied they were with the WoundExpress™ IPC device.
The main (primary) endpoint of the study was the percentage change in wound surface area at 16 weeks. Secondary endpoints included complete healing (closure of the wound), pain, quality of life, satisfaction with the device, device usage and adverse events. Exploratory analyses looked at time to healing, healing in the presence of other medical conditions (comorbidities) and differences between countries.
What were the results
Wound size reduction
At 16 weeks the median percentage reduction in ulcer area was similar in both groups: 64 % reduction in the IPC group and 68 % reduction in the control group. The mean percentage change was 48.7 % in the IPC group and –13.7 % (an increase in size) in the control group, but this difference was driven by a small number of participants with very small ulcers that got bigger. When the researchers excluded these very small wounds in an additional analysis, wound reduction remained numerically greater in the IPC group but was not statistically significant (meaning the difference could have happened by chance).
Complete healing and other secondary outcomes No meaningful differences were seen between groups in the number of wounds that completely healed, changes in pain scores or quality of life scores. The patient satisfaction with the WoundExpress™ device was generally high. Most people who took part in the IPCOTT trial said they found the device comfortable and easy to use. However, there was a noticeable difference between what patients said and how often they actually used the device. According to their personal diaries, patients reported using it for about 2 hours a day. But when researchers checked the device’s built-in usage trackers, the average was closer to 1.5 hours a day. In some cases, people used the device on only 3 to 4 days during the entire 16-week study. However, an additional analysis found that patients who used the device more did not consistently get better outcomes. Exploratory analyses looked at the time it took ulcers to heal and whether people with other illnesses healed differently, but again there were no notable differences. Analyses by country showed some variation in results, but no difference.
Safety
The device was generally safe and well tolerated. There were no new safety concerns. Adverse events occurred at similar rates in both groups, and only one adverse event (increased pain due to hosiery) was definitely related to treatment. Fourteen other events were possibly related to the treatment, but most were mild and temporary.
What do these findings mean?
The IPCOTT study shows that adding thigh administered IPC to usual care did not significantly improve healing of venous or mixed aetiology leg ulcers during a 16 week period. The overall reduction in ulcer size, rates of complete healing, pain levels and quality of life were similar whether or not participants used the WoundExpress™ device. The device was easy to use and generally acceptable, and no serious safety issues were identified.
Because the study recruited fewer participants than originally planned (136 instead of 160) due to the COVID 19 pandemic, it may not have had enough statistical power to detect small treatment differences. Another challenge in the study was that patients didn’t all use the WoundExpress™ device as much as planned, which may have affected how well the treatment worked. Future research could explore whether specific patient subgroups or longer treatment duration might benefit from IPC.
Thank you to participants
The study team thanks all patients who took part. Your involvement helps researchers understand how best to care for people with hard to heal leg ulcers and guides future improvements in wound care.
Where can I find more information?
A research article with more details of the study findings is currently being made ready for publication. For more details or questions about the study, please contact Huntleigh Healthcare Ltd (sponsor).
Glossary of technical terms
Term Meaning
Venous leg ulcer (VLU) An open sore on the leg that happens because the veins cannot return blood effectively to the heart.
Mixed aetiology leg ulcer (MLU) An ulcer caused by venous problems combined with another problem, such as poor arterial blood flow.
Intermittent pneumatic compression (IPC) A therapy that uses an inflatable sleeve connected to a pump to rhythmically squeeze the limb, improving blood and lymph flow.
WoundExpress™ A portable IPC device with a three chamber sleeve worn on the thigh; it inflates and deflates in cycles to stimulate circulation.
IPCOTT Abbreviated study title (full title: Intermittent Pneumatic Compression Of the Thigh for the Treatment of lower limb wounds: a randomised control trial)
COVID-19 pandemic A worldwide outbreak of the COVID-19 disease, which began in late 2019. Caused by the coronavirus SARS-CoV-2, the pandemic led to widespread illness, major changes in daily life, and high numbers of hospitalisations and deaths across the globe.
Comorbidity A medical condition that exists in addition to the main condition being studied.
Adverse event (AE) Any medical problem that occurs during a study, whether or not it is related to the treatment being tested.REC name
Wales REC 3
REC reference
20/WA/0307
Date of REC Opinion
19 Nov 2020
REC opinion
Favourable Opinion