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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 belowSelect...
I have been using compression therapy for my ulcer and will continue to do so.
Select...
I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.
Select...
I have a hard-to-heal wound on my lower limb due to poor blood flow.
Select...
I am 18 years old or older.
Select...
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:Select...
I have severe hardening or blockage of my arteries.
Select...
My wound is either less than 2 months old or over 5 years old.
Select...
I have been diagnosed with cancer.
Select...
My recent HbA1c level was above 8.5.
Select...
I have or might have blood clots or severe skin infections.
Select...
My leg ulcers are not caused by vein problems and I don't have severe artery disease that compression would worsen.
Select...
I don't have skin issues that would worsen with a thigh garment.
Select...
My wound is larger than 100 square centimeters.
Select...
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
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ankle-brachial index (ABPI) is at least 0.6, or if this test can't be done, you have been checked for peripheral arterial disease using other approved methods.I have severe hardening or blockage of my arteries.I have been using compression therapy for my ulcer and will continue to do so.My wound is either less than 2 months old or over 5 years old.I have been diagnosed with cancer.Your thigh is larger than 90cm around when measured with a garment.My recent HbA1c level was above 8.5.I have or might have blood clots or severe skin infections.I can use and connect a special garment to a pump by myself for 2 hours every day for 16 weeks.I am getting standard wound care that will not stop because of the study.I will not miss more than five days of therapy for any reason.My leg ulcers are not caused by vein problems and I don't have severe artery disease that compression would worsen.I am currently using additional treatments like heat or special dressings for my wound.I don't have skin issues that would worsen with a thigh garment.I have a hard-to-heal wound on my lower limb due to poor blood flow.My wound is larger than 100 square centimeters.I am 18 years old or older.I am using or willing to use birth control during the study.My wound hasn't healed by at least 25% in the last month despite proper treatment.I have severe heart failure or conditions worsened by fluid increase.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Wound Care plus IPC
- Group 2: Standard Wound Care Alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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