IPC + Standard Wound Care for Leg Ulcers
(IPCOTT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether a new device called the WoundExpress can aid in healing stubborn leg ulcers. These sores often result from vein and artery issues in the legs and sometimes resist usual treatments. The study will compare standard care alone to standard care plus this new device, which gently massages the leg to enhance blood flow. Ideal candidates for the trial have hard-to-heal leg ulcers persisting for more than two months, even after using compression therapy, such as Intermittent Pneumatic Compression of the Thigh. Participants must use the device at home for two hours daily over 16 weeks. As an unphased trial, this study provides a unique opportunity to explore a new treatment option that could potentially improve healing outcomes for leg ulcers.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must continue receiving standard wound care and compression therapy during the study.
What prior data suggests that this IPC device is safe for treating leg ulcers?
Research shows that intermittent pneumatic compression (IPC) is generally safe and comfortable for patients. In past studies, IPC effectively helped ulcers heal more quickly. For example, one study found that 62% of ulcers treated with IPC healed, compared to only 28% of those treated with just dressings.
No major reports of harmful side effects from IPC devices exist. Most patients find the device's pressure gentle and comfortable, as it is less than the pressure used in regular blood pressure checks. This suggests that IPC is safe for treating leg ulcers. However, anyone interested in joining a trial should discuss any concerns with their doctor.12345Why are researchers excited about this trial?
Researchers are excited about using Intermittent Pneumatic Compression (IPC) for leg ulcers because it offers a new way to enhance healing. Unlike standard compression therapies, which typically involve static bandages or stockings, IPC uses a dynamic mechanism that alternates pressure on the thigh to improve blood flow. This technique may accelerate healing by more efficiently reducing swelling and promoting circulation, potentially leading to faster recovery times for patients.
What evidence suggests that the WoundExpress device is effective for healing leg ulcers?
Research has shown that Intermittent Pneumatic Compression (IPC), which participants in this trial may receive alongside standard wound care, can aid in healing venous leg ulcers. One study found that 86% of ulcers healed faster with IPC compared to 61% with a slower method. Another report suggested that IPC creates a better healing environment, accelerating recovery. Additionally, IPC works as effectively as traditional bandage compression for treating venous ulcers. Importantly, IPC may also help manage pain without causing serious side effects.13678
Are You a Good Fit for This Trial?
Adults with chronic venous or mixed-origin leg ulcers, who've had unsuccessful healing despite compression therapy, can join. They must be able to use the IPC device at home for 2 hours daily over 16 weeks and continue standard wound care. Exclusions include severe vascular diseases, large or very old/new wounds, uncontrolled diabetes, recent serious cardiovascular events, current pregnancy or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard wound care plus IPC or standard wound care alone for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants in Group B are offered the chance to use the WoundExpress device for a 16-week period after the study has ended
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Pneumatic Compression of the Thigh
Find a Clinic Near You
Who Is Running the Clinical Trial?
Huntleigh Healthcare Ltd
Lead Sponsor
SerenaGroup, Inc.
Collaborator