What side effects are associated with this type of intervention?

Intermittent Pneumatic Compression (IPC) is commonly used to improve circulation and promote healing in venous leg ulcers. Known side effects of IPC include discomfort or pain during use, skin irritation, and, in rare cases, worsening of edema or deep vein thrombosis. Compression bandaging, another common treatment, can cause skin irritation, pressure sores, and discomfort. It is important for patients to be monitored regularly to mitigate these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for venous leg ulcers, including compression therapy methods such as compression bandages and stockings. Intermittent Pneumatic Compression (IPC) devices, like the WoundExpress, are also used to improve circulation and promote ulcer healing. These devices work by inflating and deflating a sleeve around the leg to enhance blood flow. While specific FDA approvals for IPC devices in the context of venous leg ulcers are not detailed, these devices are widely recognized and utilized in clinical practice for their efficacy in managing chronic venous insufficiency and associated ulcers.

What other types of research exist?

Promising alternatives to WoundExpress for VLU patients include: 1) Advanced multilayer compression bandaging systems, which have shown efficacy in improving circulation and ulcer healing. 2) Negative Pressure Wound Therapy (NPWT), which can enhance wound healing by promoting blood flow and reducing edema. 3) Bioengineered skin substitutes and growth factor therapies, which can accelerate healing by providing a conducive environment for tissue regeneration. 4) Electrical stimulation therapy, which has been found to improve wound healing by enhancing blood flow and cellular activity. These alternatives should be discussed with a healthcare provider to determine the most appropriate treatment based on individual patient needs.

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IPC + Standard Wound Care for Leg Ulcers (IPCOTT Trial)

N/A

Waitlist Available

Research Sponsored by Huntleigh Healthcare Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has received high static compression therapy (in the form of bandages, wraps or hosiery) during the preceding 4 weeks and is willing to continue receiving appropriate static compression therapy for their ulcer aetiology for the duration of the study

Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16 week period

Must not have

Severe arteriosclerosis or other ischemic vascular disease

Wound duration ≤ 2 months or ≥ 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Summary

This trial is testing a new device called WoundExpress to help heal stubborn leg ulcers. The device gently squeezes the thigh to improve blood flow, which can help ulcers heal faster. The study aims to see if WoundExpress makes a difference in healing.

Who is the study for?

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.

What is being tested?

The trial is testing if adding Intermittent Pneumatic Compression (IPC) using a thigh sleeve called WoundExpress improves healing of leg ulcers compared to standard wound care alone. Participants are randomly assigned to either receive the IPC device plus usual care or just usual care for a period of 16 weeks.

What are the potential side effects?

Potential side effects from using the IPC device may include discomfort at the site of application and skin irritation under the garment. There's also a low risk of worsening any existing skin infections due to pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using compression therapy for my ulcer and will continue to do so.

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I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.

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I have a hard-to-heal wound on my lower limb due to poor blood flow.

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I am 18 years old or older.

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My wound hasn't healed by at least 25% in the last month despite proper treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe hardening or blockage of my arteries.

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My wound is either less than 2 months old or over 5 years old.

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I have been diagnosed with cancer.

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My recent HbA1c level was above 8.5.

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I have or might have blood clots or severe skin infections.

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My leg ulcers are not caused by vein problems and I don't have severe artery disease that compression would worsen.

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I don't have skin issues that would worsen with a thigh garment.

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My wound is larger than 100 square centimeters.

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I have severe heart failure or conditions worsened by fluid increase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the effect of thigh administered IPC on the healing of lower limb wounds of venous or mixed etiology

Secondary study objectives

Assess patient acceptability of IPC therapy

Assess safety of IPC therapy

Assess the cost effectiveness of IPC as a treatment for venous and mixed etiology leg ulcers

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Wound Care plus IPCExperimental Treatment1 Intervention

Patients receiving gold standard compression therapy plus IPC (WoundExpress)

Group II: Standard Wound Care AloneExperimental Treatment1 Intervention

Patients receiving gold standard compression therapy for venous or mixed etiology ulcers

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stand Wound Care plus IPC

2023

N/A

~140

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Venous Leg Ulcers (VLU) include compression therapy, which aims to improve venous return and reduce venous hypertension. Intermittent Pneumatic Compression (IPC) is a key method, involving a sleeve that inflates and deflates around the leg to mimic the natural muscle pump action, enhancing blood flow back to the heart. This mechanism reduces edema, improves oxygen and nutrient delivery to the affected tissues, and accelerates ulcer healing. For VLU patients, effective circulation is crucial as it mitigates the underlying venous insufficiency, thereby promoting faster and more effective wound healing.