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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

Huntleigh Healthcare LtdLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
SerenaGroup, Inc.NETWORK
29 Previous Clinical Trials
3,292 Total Patients Enrolled

Media Library

Intermittent Pneumatic Compression of the Thigh Clinical Trial Eligibility Overview. Trial Name: NCT05659394 — N/A
Venous Leg Ulcer Research Study Groups: Standard Wound Care plus IPC, Standard Wound Care Alone
Venous Leg Ulcer Clinical Trial 2023: Intermittent Pneumatic Compression of the Thigh Highlights & Side Effects. Trial Name: NCT05659394 — N/A
Intermittent Pneumatic Compression of the Thigh 2023 Treatment Timeline for Medical Study. Trial Name: NCT05659394 — N/A
~49 spots leftby Nov 2025